Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Learn more about:
Related Clinical Trial
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

Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Official Title

Investigator-Initiated, Double Blind, Two-Armed, Placebo-Controlled, Randomized Clinical Trial With an Open-Label Extension Phase, to Investigate Efficacy of 5% Minoxidil Topical Foam Twice Daily in Men With Androgenetic Alopecia in the Temple and Vertex Region Concerning Hair Volume Over 24 / 104 Weeks

Brief Summary

      The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical
      Foam (MTF) formulation compared to placebo in the temple region of male patients with
      androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and
      safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2
      years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all
      patients will get the equal treatment and measurements in the vertex region to enable
      comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline
      but also to vertex region. Additionally safety assessments will be performed throughout the
      whole study.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks

Secondary Outcome

 Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)

Condition

Androgenetic Alopecia

Intervention

Minoxidil

Study Arms / Comparison Groups

 vehicle of 5% Minoxidl topical foam
Description:  vehicel foam in twice daily application in temple and vertex region

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

Drug

Estimated Enrollment

70

Start Date

November 2010

Completion Date

March 2013

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Male, age 18 to 70 year old, in general good health

          -  Exhibits male AGA based on a discernable hair loss in temple and vertex region rating
             Hamilton-Norwood Scale III vertex to VI (See Appendix 1)

          -  Subjects who give their consent to the study after thorough explanation and who
             personally signed and dated the informed consent document indicating that the subject,
             has been informed of all pertinent aspects of the trial

          -  Willing to maintain the same hairstyle, hair length and hair color throughout the
             study

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             mini-tattoo and other trial procedures

          -  Accepting the Information form plus accepting and signing the Informed Consent form

        Exclusion Criteria:

          -  Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink,
             fragrances, hair gel or any vehicle components

          -  Current or 4 weeks dated back use of medical shampoos or solutions which include
             Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the
             CTM or examination method

          -  Current or 3 months dated back use of topical treatment in the target regions taken
             for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids,
             aminexil, minoxidil, estrogens)

          -  Current or 3 months dated back use of systemic treatment (drugs or dietary supplement)
             taken for more than 2 consecutive weeks interfering with the CTM or examination method
             (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake
             above 10000 IU per day)

          -  Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.),
             Dutasteride or a similar product

          -  Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as
             radiation and/or laser/surgical therapy of the scalp

          -  Current or prior enrollment in any other investigational medication (drug) study
             within the 4 weeks prior to study initiation

          -  Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding

          -  Current or 2 months dated back severe diet or presenting a history of eating disorder

          -  Any dermatological disorders of the scalp in the target region with the possibility of
             interfering with the CTM or examination method, such as fungal or bacterial
             infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp
             atrophy

          -  Untreated persisting hypertension

          -  Active hair loss or history within the past 3 months including diffuse telogen
             effluvium, alopecia areata, scarring alopecia

          -  Other severe, acute or chronic medical condition that may lead to hair loss or
             interfere with the interpretation of trial results (e. g. untreated hypothyroidism)

          -  Individuals who are institutionalized by court or regulatory order
      

Gender

Male

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01319370

Organization ID

CRC-AGA02

Secondary IDs

2010-018291-25

Responsible Party

Sponsor-Investigator

Study Sponsor

Natalie GARCIA BARTELS

Collaborators

 Johnson & Johnson

Study Sponsor

, , 


Verification Date

November 2013