A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers

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Brief Title

A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers

Official Title

A Randomized, Double-blind, Vehicle-controlled, Dose-finding Multi-center, Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers With Androgenetic Alopecia

Brief Summary

      This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter
      dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical
      formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16
      weeks in healthy male subjects with androgenetic alopecia.
    

Detailed Description

      This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter
      dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical
      formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16
      weeks in healthy male subjects with androgenetic alopecia.

      The trial will be performed at three centers in Germany. The aim of the trial is to determine
      the most efficacious dose of FOL-005 topical formulation based on efficacy dose trends. It is
      planned to randomize 220 subjects (with a ratio 1:1:1:1 FOL-005 0.1%; FOL-005 0.5%; FOL-005
      1.5%; vehicle).

      The trial consists of a screening period of up to three weeks and a treatment period of 16
      weeks.

      Eligible subjects will be randomized at Baseline (Day 1) and will apply the investigational
      products themselves at home once daily for 16 weeks. Subjects will return to the sites bi-
      weekly for check of compliance and assessment of local tolerability. At Day1, Day 84 and Day
      112 subjects will be evaluated for hair growth parameters by TrichoLAB imaging. The end of
      the clinical trial for each individual subject is defined as the Final Visit at Day 112. In
      case of premature termination of a randomized subject an Early Termination (ET) visit should
      be performed.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in total hair density at week 16

Secondary Outcome

 Change in total hair density at week 12

Condition

Androgenetic Alopecia

Intervention

Topical formulation

Study Arms / Comparison Groups

 FOL- 005 (0.1 %)
Description:  topical formulation

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

209

Start Date

June 24, 2020

Completion Date

January 29, 2021

Primary Completion Date

January 29, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy male, aged 18-55 years

          2. Skin phototype II, III and IV according to Fitzpatrick's classification (Fitzpatrick
             et al. 1974)

          3. Androgenetic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5,
             5A, 5V (Hamilton, 1951)

          4. Willing and able to comply with scheduled visits

          5. Willing to maintain the same hair hygiene products and general hair care habits during
             the trial period

          6. Willing to maintain the same hair length and hair color during the trial period

          7. Willing to have treatment areas shaved for TrichoLAB® measurement and marked with
             small semi-permanent dot tattoos

          8. Willing to avoid prolonged UV exposition and UV tanning beds

          9. Signed written informed consent before participation in the trial.

         10. Subjects with a hair length of above 1 cm

        Exclusion Criteria:

          1. Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos,
             scars or other disfiguration of the test sites risking to interfere with
             investigational evaluations

          2. Any dermatological disorders of the scalp which might interfere with the application
             of the investigational product (IP) or examination method, such as fungal or bacterial
             infections, seborrheic dermatitis (except mild forms which are managed with OTC
             shampoos and which do not require dermatological treatment), psoriasis, eczema,
             folliculitis, that require chronic use of medication or scalp atrophy

          3. Any skin pathology (e.g. scar, nevus) or general condition (e.g. uncontrolled thyroid
             diseases) that in the Investigator's opinion can interfere with the evaluation of the
             test areas or requires prohibited topical or systemic therapy

          4. History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen
             effluvium or conditions other than androgenetic alopecia

          5. Diabetes mellitus

          6. Presence of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis,
             atopic dermatitis, porphyria, folliculitis) or presence or history of known skin
             cancer that in the opinion of the Investigators might confound the results of the
             trial

          7. History or clinical signs of keloids or hypertrophic scars

          8. Immunological disorders such as alopecia areata, and systemic lupus erythematosus and
             other systemic known autoimmune disorders

          9. Current or within the last 6 months history of severe dietary or weight changes

         10. Hair transplantation at any time

         11. Known sensitization to cosmetic hair dyes or hypersensitivity to any ingredients of
             the IP or tattoo ink.

         12. Application of topical minoxidil preparation or any other topical over-the counter
             (OTC) or prescription medication for hair re-growth to scalp for 4 weeks or more
             during a 6 months period before enrollment.

         13. Use of or planned use of shampoo with expected medicinal effect on the scalp (e.g. but
             not limited to anti-dandruff containing ketoconazole, anti-psoriatic, anti-fungal or
             shampoo containing urea, caffeine, acetylsalicylic acid, etc.) during the course of
             trial

         14. Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids or
             other treatments that may affect hair growth in the last 3 months as well as during
             the trial.

         15. Platelet rich plasma (PRP) or any mesotherapy treatment on scalp during the last 12
             months as well as during the trial.

         16. Systemic therapy using retinoids, cyclosporine, beta blockers or corticosteroids
             within the last 6 months as well as during the trial.

         17. Scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months
             as well as during the trial.

         18. Finasterid (e.g. Propecia®) or Dutasteride intake or topical application in the last
             12 months, or any systemic hair therapy medication in the last 12 months as well as
             during the trial.

         19. Other systemic therapy which in the opinion of the Investigator might affect hair
             growth

         20. Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g.
             Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new
             oral anticoagulants, regular intake of acetylsalicylic acid)

         21. Current or within 3 months prior to first dosing use of systemic corticosteroids (nose
             drops, eye drops and/or inhalers are permitted) or other immunosuppressive drugs (e.g.
             cyclosporine A)

         22. Elevated values for vital signs: blood pressure: systolic above 160 mmHg, diastolic
             above 95 mmHg, pulse rate: above 100 beats/min

         23. Planned or scheduled subject surgery or hospitalisation during the course of the trial

         24. Previously randomized in this trial (only valid for subjects included after 01JUN2020)

         25. Psychiatric conditions that might limit the participation in the trial and/or that
             lead to the assumption that the ability to completely understand the consequences of
             consent is missing.

         26. Subjects, who are inmates of psychiatric wards, prisons or state institutions.

         27. Participation in a clinical trial with investigational medicinal products within the
             last 30 days prior to the Day 1 and / or during this trial.

         28. Employees of the trial sites who are directly involved in this trial or employees of
             the Sponsor's company.

         29. If in the opinion of the Investigator the subject should not participate in the trial
             for any reason.
      

Gender

Male

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ulrike Blume-Peytavi, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04774874

Organization ID

FCS-003


Responsible Party

Sponsor

Study Sponsor

Follicum AB

Collaborators

 proDERM GmbH

Study Sponsor

Ulrike Blume-Peytavi, Principal Investigator, Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin


Verification Date

February 2021