A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss

Learn more about:
Related Clinical Trial
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending Topical Cetirizine in Androgenetic Alopecia in Females A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss Anti-Androgen Treatment for COVID-19 A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss The Effect of Platelet Rich Plasma on Non-scarring Alopecia Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter HairDx Analytical Validation Study The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899) A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669) A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542) A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541) To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study To Evaluate the Pharmacokinetics and Safety of AD-208 The Utility of Platelet Rich Plasma in Hair Loss Computer-Assisted Versus Manual Hair Harvest Comparative Study Topical Bimatoprost Effect on Androgen Dependent Hair Follicles Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512) PAI-1 Expression in Non-scarring Hair Loss Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Cold Plasma to Treat Hair Loss Adipose-derived SVF for Treatment of Alopecia Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss Photosensitization Study in Androgenetic Alopecia Point-of-Care Adipose-derived Cells for Hair Growth Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application Modulated Light Therapy in Participants With Pattern Hair Loss Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia N-Acetyl-Cysteine for Treatment of AGA in Men Clinical Trial in Females for Female Pattern Hair Loss Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111) Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5% Treatment of Androgenetic Alopecia in Males and Females Microarray Analysis of Scalp Biopsies After Minoxidil Treatment Efficacy of Platelet-Rich Plasma Therapy for Androgenetic Alopecia: A Systematic Review and Meta-analysis 24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Minoxidil Response Testing in Males With Androgenetic Alopecia Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia Study to Assess Efficacy of Platelet-Rich Plasma in Androgenetic Alopecia The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA) Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution Treatment of Androgenetic Alopecia in Females, 9 Beam Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing Treatment of Androgenetic Alopecia in Males Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction Treatment of Androgenetic Alopecia in Females, 12 Beam Nanofat Grafting for Treatment of Androgenetic Alopecia Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females Treatment of Androgenic Alopecia in Males A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia Androgenetic Alopecia and the JAK-STAT Pathway Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment Efficacy and Safety of Platelet Rich Plasma in Androgenetic Alopecia The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

Brief Title

A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss

Official Title

Hair Regrowth Efficacy of Multi-Molecular Targeting Treatment (ALRV5XR), a Randomized Controlled Clinical Trial in Men With Androgenetic Alopecia, Telogen Effluvium or Self Reported Thinning Hair: THE HAIR REBOOT TRIAL - MEN

Brief Summary

      To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily
      shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting
      hair growth as assessed by change in hair density and percentage of terminal hair regrowth
      after ALRV5XR therapy.

      This will be a single-centre, double-blind, randomized, placebo-controlled study in male
      subjects randomized to a 1:1 ratio of test article to placebo.

      Subjects will be asked to use the study products on a daily basis for the duration of the
      24-week study. Subjects will take one capsule twice daily (one in the morning and one in the
      evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of
      the topical nutriment daily. Subjects will receive detailed instructions regarding the order
      and duration of application of each product.

      Subjects in the active arm will receive active capsules, shampoo, conditioner and topical
      nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and
      topical nutriment. All subjects will be instructed to take the capsules orally, one in the
      morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be
      used once per day when washing the hair and nutriment applied at the end of the day prior to
      bedtime. To facilitate this, subjects will receive a 3-month supply of each product
      (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily
      regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.
    

Detailed Description

      This is a prospective, randomized, double-blind, placebo-controlled, 2-arm parallel study to
      evaluate the efficacy and safety of a multi-molecular targeting botanical treatment regimen
      on parameters of hair growth, compared to placebo, in healthy male adults with androgenetic
      alopecia, diffuse hair loss or self-reported thinning hair.

      Each study group will include 23 subjects. Subjects will be randomly assigned using computer
      generated randomization scheme to one of the two groups in a 1:1 ratio.

      Subjects will be asked to use the study products on a daily basis for the duration of the
      24-week study. Subjects will take one capsule twice daily (one in the morning and one in the
      evening) and will be instructed to use 3-7mL of the shampoo, 3-7mL of the conditioner, and
      1mL of the topical nutriment serum daily. Subjects will receive detailed instructions
      regarding the order, and duration of application of each product.

      This trial will be conducted at one (1) American (USA) clinical research site. The duration
      of the study will be approximately 28 weeks (7 months), including the screening period. There
      will be a screening period of up to 28 days for eligibility assessment, followed by a
      baseline visit followed by a 24-week experimentation period for assessment of supplement
      effects. There will be a total of seven visits, including a screening visit, over this
      28-week period.

      The study will be conducted as outlined in this protocol and in compliance with the
      principles of the International Conference on Harmonization (ICH) Guidelines on Good Clinical
      Practice (GCP) (E.6), and the Declaration of Helsinki.

      Prior to initiating any study-related procedures, each subject must provide written informed
      consent in accordance with Institutional Research Board (IRB) requirements and applicable
      regulations. Any potential subject will be contacted by a designated member of the research
      team at the study site. Potential subjects may complete a web-based pre-screening
      questionnaire or may be interviewed. During the interview (or web-based questionnaire),
      subjects will answer specific questions, in order to assess their eligibility. If they meet
      pre-screening requirements, they will be invited to schedule a screening visit (Visit 1) with
      a Study Coordinator no more than 30 days prior to the anticipated baseline visit (Visit 2).
      In the event that subjects' screening period exceeds 30 days, the Investigator may repeat
      blood work, biometrics and/or vital signs (as appropriate) to ensure that subjects remain
      eligible.

      Visit 1 (Screening Visit):

      At the screening visit (Visit 1), up to 30 days prior to the Baseline Visit (Visit 2), the
      overall details of the study and the procedures to be undertaken will be explained to the
      subject. The following information will be recorded and procedures carried out:

        -  Subject registration

        -  Informed Consent (copy to subject)

        -  Subject education/comprehension questionnaire

        -  Review inclusion & exclusion criteria

        -  Assess Fitzpatrick phototype skin classification

        -  Demographic data (dietary habits, race, ethnicity, age, etc.)

        -  Medical history

        -  Concomitant medications recorded

        -  Measure screening anthropometrics and vital signs: height (cm), weight (kg), temperature
           (°C) respiratory rate (breaths/min), blood pressure (mmHg) and heart rate (bpm).

        -  Calculate BMI (kg/m2)

        -  Scalp examination (including photographs) for each subject will include a screen for
           immediately observable medical issues and any scalp alopecia/scalp disorders;
           photography of hair (top, right side, left side, back) - photographs will be shared with
           the Sponsor for determination of eligibility to participate in the study.

        -  Physical examination (excluding breast, genital and anorectal exam)

        -  Collect fasting (>6h, nothing to eat or drink except water) blood for screening
           laboratory tests

        -  Provide the subject with an instruction handout explaining visit preparation and overall
           study requirements (provide written and verbal instructions).

      Remind subjects to follow inclusion/exclusion criteria of restrictions for both OTC and
      prescription medications, maintain current dietary habits, sleep habits, exercise and sexual
      intercourse habits.

      If the subject is eligible for the study, they will be given a date to attend the Site no
      more than 30 days after the screening visit.

      Visit 2 (Baseline Visit) - Day 0 Inclusion/Exclusion Criteria will be re-assessed to ensure
      eligibility. Concomitant medications and adverse events (AE's) will be reviewed. Eligible
      subjects will be randomized to one of the two treatment arms.

      The following procedures will be completed prior to dosing:

        -  Monitor adverse events (since the previous visit)

        -  Review concomitant medications

        -  Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate
           (breaths/min), blood pressure (mmHg) and heart rate (bpm)

        -  Calculate BMI (kg/m2)

        -  Review inclusion & exclusion criteria

        -  Scalp examination (including photographs) for each subject will include a screen for
           observable medical issues and any skin/scalp disorders; photography of hair (top, right
           side, left side, back) - photographs will be reviewed and SALT score determined by a
           dermatologist. General photographic instructions are described in APPENDIX III.

        -  Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

        -  Use Trichology device to capture images of scalp target area for efficacy assessments

        -  Randomize eligible subjects

        -  Provide subject with the first dose of the oral supplement in clinic

      The following procedures will be completed after dosing:

        -  Monitor subject for any immediate reactions (minimum 15-minute observation post-
           administration)

        -  Dispense 3-month supply of investigational product

        -  Provide subjects with instruction for using kit contents

        -  Remind subjects to follow inclusion/exclusion criteria for restrictions for both OTC and
           prescription medications, maintain current dietary habits, sleep habits, exercise and
           sexual intercourse habits.

        -  Provide subjects with a diary to record product use and any changes to health status or
           medication use

      Visit 3 (Return for anagen/telogen ratio assessment) - day 3 Subjects will return to the
      clinic on day 3 to have the baseline anagen/telogen ratio assessed.

      Visit 4 (Interim Visit) - Day 84 Study subjects will return to the Clinic on Day 84.

      The following procedures will be completed:

        -  Collect daily diaries and review

        -  Collected investigational product containers (used and unused) and assess compliance

        -  Monitor adverse events (since the previous visit)

        -  Review concomitant medications (including changes to medications, changes to dose and
           frequency)

        -  Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate
           (breaths/min), blood pressure (mmHg) and heart rate (bpm)

        -  Calculate BMI (kg/m2)

        -  Scalp examination (including photographs) for each subject will include a screen for
           observable medical issues and any skin/scalp disorders; photography of hair (top, right
           side, left side, back) - photographs will be reviewed and SALT score determined by a
           dermatologist.

        -  Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

        -  Use Trichology device to capture images of scalp target area for efficacy assessments

        -  Collect blood for safety laboratory tests

        -  Dispense 3-month supply of investigational product

        -  Provide subjects with instruction for using kit contents

        -  Remind subjects to follow inclusion/exclusion criteria for restrictions for both OTC and
           prescription medications, maintain current dietary habits, sleep habits, exercise and
           sexual intercourse habits

        -  Provide subjects with a diary to record product use and any changes to health status or
           medication use

        -  Subjects will be booked for their next appointment

      Visit 5 (Return for anagen/telogen ratio assessment) - day 87 Subjects will return to the
      clinic to have the anagen/telogen ratio assessed.

      Visit 6 - Day 168 Study subjects will return to the Clinic on Day 168.

      The following procedures will be completed:

        -  Collect daily diaries and review

        -  Collected investigational product containers (used and unused) and assess compliance

        -  Monitor adverse events (since the previous visit)

        -  Review concomitant medications (including changes to medications, changes to dose and
           frequency)

        -  Measure anthropometrics and vital signs: weight (kg), temperature (°C) respiratory rate
           (breaths/min), blood pressure (mmHg) and heart rate (bpm)

        -  Calculate BMI (kg/m2)

        -  Scalp examination (including photographs) for each subject will include a screen for
           observable medical issues and any skin/scalp disorders; photography of hair (top, right
           side, left side, back) - photographs will be reviewed and SALT score determined by a
           dermatologist.

        -  Subjects will be asked to complete the Dermatology Quality of Life Index (DQLI)

        -  Use Trichology device to capture images of scalp target area for efficacy assessments

        -  Collect blood for safety laboratory tests

      Visit 7 (Return for anagen/telogen ratio assessment and end of study assessment) - day 171
      Subjects will return to the clinic on day 3 to have the baseline anagen/telogen ratio
      assessed.

      Early Termination/Discontinuation Visit

      Subjects may elect to independently withdraw from participation in the study at any time. At
      a termination visit, subjects will be encouraged to undergo the procedures specified in the
      final study visit. Reasons for early termination/ discontinuation may include the subject
      developing any condition which contravenes the original criteria, or, at the discretion of
      the Principal Investigator (PI), the subject is considered to be unsuitable to continue the
      study. Individual subjects may have administration temporarily interrupted at the discretion
      of the PI, e.g. for AEs that are subsequently resolved. Subjects MUST have permanent
      discontinuation in the following situations:

        -  The subject had a Grade 3 (severe) or an investigational product-related SAE as
           determined by the PI

        -  Subject withdraws consent or refuses further assessment during the study

        -  Participation in another clinical trial

        -  Subject lost to follow-up

        -  Death

        -  Protocol violation

      Unscheduled Visits Any study participant who contacts the investigation site about possible
      adverse events that are more than minor and/or that persist will be asked to visit the
      research centre for an assessment as appropriate.

      Safety Tests Blood will be collected at V1, V4 and V6 for analysis of safety parameters.
      Anthropometrics and vital signs are being recorded at study visits number 1, 4, and 6 as
      measures of safety. Additionally, safety will be assessed by means of reported AEs.

      Stopping Rules/Discontinuation The Investigator may withdraw any subject from this research
      if circumstances arise that warrant doing so. If a subject is withdrawn from the study for
      any reason, they will be asked to complete an early termination visit.

      Permitted/Concomitant Medication(s) Subjects will be questioned about their medication
      history. The details of any medication taken will be recorded in the case notes and
      electronic Case Report Form (eCRF). Prescription and over-the-counter (OTC) medications
      (including supplements) not known to affect study endpoints are permitted.

      Thyroid medications will be permitted where dosage has been stable for 6 months prior to the
      screening visit (V1) and subjects are not expected to have a dosage change during the study
      period.

      Prohibited Medication(s)

      Medications that are prohibited include:

        -  Anabolic steroids in prior 6 months and during the clinical study period

        -  5-alpha reductase inhibitors in prior 6 months and during the clinical study period

        -  Products (including natural health products) and/or devices to promote scalp hair growth
           (e.g. finasteride, minoxidil, etc.) in 30 days prior to baseline (V2) and during the
           clinical study period

        -  Medications that are known to potentially cause hair loss or affect growth as determined
           by PI in 30 days prior to baseline (V2) and during the clinical study period

        -  Use of coagulation inhibiting medications (including natural health products) during the
           clinical study period

        -  Use of blood pressure lowering medications during the clinical study period

        -  Use of anti-inflammatory medications, corticosteroids or immunosuppressive drugs taken
           for more than 2 consecutive weeks in the 3 months prior to baseline (V2) and during the
           clinical study period

      Rescue Medication(s) As this study is investigating the effects of a product in a healthy
      population, there are no rescue medications in this study.

      SELECTION AND WITHDRAWAL OF SUBJECTS NUMBER OF STUDY PARTICIPANTS It is estimated that up to
      70 subjects will be screened, in order to identify 46 suitable subjects.

      WITHDRAWAL CRITERIA Subjects may withdraw from participation in a study at any time without
      consequence. If a subject withdraws from the study, the PI will make a reasonable effort to
      determine the reason for withdrawal from the study, which will be recorded on the eCRF, as
      will any AEs experienced by the subject.

      Personal reasons (Subject-initiated): Participation in the study is optional, and a subject
      can withdraw from the study at any time, without consequence or prejudice.

      Clinical judgment of PI: A subject could also be withdrawn from the study if, in the opinion
      of the PI, it is not in the subject's best interest to continue (e.g. AEs, need for
      prohibited medication, illness, etc.). All serious AEs (SAEs) will result in withdrawal from
      the trial.

      Protocol violation: If a subject fails to comply with the protocol they may be removed at the
      discretion of the PI.

      Reasons for withdrawal will be documented as one of the following:

      W.1 Subject requests withdrawal from the study. W.2 Subject withdraws consent. W.3 AE makes
      the continuation of the subject in the study impossible or inadvisable.

      W.4 Subject was incorrectly included in the study (discovered after enrollment not to have
      met the protocol entrance criteria). W.5 Subject is not complying with required study
      procedures.
    


Study Type

Interventional


Primary Outcome

Change in terminal hair density from baseline to Week 24.

Secondary Outcome

 Change in terminal hair density from baseline

Condition

Androgenetic Alopecia

Intervention

ALRV5XR

Study Arms / Comparison Groups

 ALRV5XR
Description:  The ALRV5XR (active) group will receive ALRV5XR active treatment. Study agents will have randomized codes. Supplement capsules, shampoo, conditioner and scalp serum will all be similar in look and scent to the placebo products.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

46

Start Date

April 11, 2018

Completion Date

October 23, 2018

Primary Completion Date

October 23, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Men 18 - 65 years of age at time of screening (V1) (inclusive).

          2. Have androgenetic alopecia, diffuse hair loss or self-reported thinning or hair loss
             for more than 3 months prior to screening (V1).

          3. Clinically confirmed to have hair loss or thinning by the investigator via physical
             exam.

          4. In good general health, as determined by the Investigator.

          5. Willing and able to attend all study visits.

          6. Willing to maintain the same hair style as at the Screening Visit and refrain from
             chemical treatments on the hair for the duration of the study.

          7. Have Fitzpatrick skin type I-IV.

          8. Be willing and able to cooperate with the requirements of the study.

          9. Willingness to be photographed and provide consent for photographic release.

         10. Voluntarily sign and date an informed consent approved by the Institutional Review
             Board.

         11. Be able to complete and understand the various rating instruments in English.

         12. Sponsor approved global image assessment of degree of thinning / hair loss.

        Exclusion Criteria:

          1. Female

          2. Clinical diagnosis of scarring forms of alopecia or alopecia areata.

          3. Clinical diagnosis on the scalp of psoriasis, scaling, fungal or bacterial infection,
             lesions, follicular dermatitis, lice, flees or chemical burns, unusual thinning
             patches, traction alopecia or trichokryptomania, trichothiodystrophy, pili annulati,
             monilethrix or clear signs of trichodysmorphia, poor nutrition or hygiene.

          4. Damage to the skin in or around the assessment areas.

          5. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.

          6. History of surgical correction of hair loss on the scalp - hair transplants or hair
             weave.

          7. Are using or have used depilatories, razors, or wax on the scalp to an extent which,
             in the opinion of the investigator, may interfere with the performance of the study
             assessments

          8. In the opinion of the investigator have very little contrast between hair color and
             scalp that would make trichometric analyses difficult.

          9. Subjects who are planning a family and becoming pregnant with their partners during
             the course of the study or subjects who are unwilling to use appropriate
             contraceptives for the duration of the study.

         10. Current skin disease or conditions on the treatment area that, in the opinion of the
             Investigator, might put the subject at risk or interfere with the study conduct or
             evaluations.

         11. Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or
             liver disease.

         12. History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain
             injury, etc.).

         13. History of blood clotting disorders or current use of coagulation-inhibiting
             medications including natural health products (e.g. warfarin, St. John's wort).

         14. Hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or
             diastolic blood pressure ≥90 mmHg or current use of blood pressure lowering
             medications.

         15. Recently started (<6 months) using hormone replacement therapy.

         16. Use of anabolic steroids or 5-alpha reductase inhibitors in 6 months prior to the
             baseline visit (V2).

         17. Use of any products (prescription, OTC or natural health products) or devices reported
             and used to promote scalp hair growth (e.g., finasteride or minoxidil, L-Tyrosine)
             within 90 days prior to the Baseline Visit (V2).

         18. Use of any medications (including natural health products) that are known to
             potentially cause hair loss or affect hair growth within 30 days prior to the Baseline
             Visit (V2), as determined by PI.

         19. History of malignancy (in past 5 years) or undergoing chemotherapy or radiation
             treatments.

         20. A known history of autoimmune disease (e.g. HIV/AIDS, systemic lupus erythematosus,
             inflammatory bowel disease, alopecia areata, alopecia totalis, etc.), uncontrolled
             thyroid disease [hyperthyroidism, hypothyroidism; controlled will be permitted if no
             changes in dosage are required in the 6 months prior to screening (V1)], hepatitis C,
             or any other disorders that in the opinion of the investigator may interfere with the
             study treatment.

         21. Concurrent or within 3 months of baseline (V2) use of anti- inflammatory medication,
             corticosteroids, or immunosuppressive drugs taken for more than 2 consecutive weeks

         22. Active psychiatric disease (hospitalized within the past 12 months of Screening).

         23. Evidence of hepatic or renal dysfunction as evidenced by ALT or aspartate
             aminotransferase (AST) being ≥ 2 times the upper limit of normal or serum creatinine
             value ≥ 1.5X the upper limit of normal or other clinically significant abnormal
             clinical laboratory value, such that patient would be classified as stage 3b or
             greater of chronic kidney failure (eGFR below 60 ml/mjn/1.73 cm2, albumin-creatinine
             ratio(ACR) > 3.0 mg/mmol), under treatment for uncontrolled hypertension(HT) and other
             factors per PI discretion.

         24. History of drug or alcohol abuse in the past 12 months prior to Screening.

         25. Currently consuming more than 2 standard alcoholic beverages a day. A standard
             alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5
             ounces of liquor.

         26. Have a known sensitivity or allergy to any ingredients in the test products or placebo
             products.

         27. Any condition or abnormality that, in the opinion of the investigator, would
             compromise the safety of the subject or the quality of the study data.

         28. Participating in or has participated in another research study within 30 days prior to
             screening with any investigational medical product or natural health product
      

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Luciano Marra (Medical Director), PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04450589

Organization ID

ALL-180001-01


Responsible Party

Sponsor

Study Sponsor

Arbor Life Labs


Study Sponsor

Luciano Marra (Medical Director), PhD, Study Director, Arbor Life Labs


Verification Date

June 2020