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

NCT04774874 | Completed Phase 2

• 1 other identifier: FCS-003
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Change in total hair density at week 16

  The change in total (terminal+vellus) hair density (hair count (n per cm²)) from Baseline to Day 112

  16 weeks

Secondary Outcomes (6)

• Change in total hair density at week 12

  12 weeks

• Change in terminal hair density at week 16

  16 week

• Change in vellus hair density at week 16

  16 week

• Change in telogen hair density at week 16

  16 weeks

• Change in anagen hair density at week 16

  16 weeks

Study Arms (4)

FOL- 005 (0.1 %)

EXPERIMENTAL

topical formulation

Drug: Topical formulation

FOL -005 (0.5 %)

EXPERIMENTAL

topical formulation

Drug: Topical formulation

FOL -005 (1.5 %)

EXPERIMENTAL

topical formulation

Drug: Topical formulation

Vehicle

PLACEBO COMPARATOR

topical formulation

Drug: Topical formulation

Interventions

Topical formulation DRUG

Topical administration on the scalp once daily for 16 weeks

FOL -005 (0.5 %); FOL -005 (1.5 %); FOL- 005 (0.1 %); Vehicle

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male, aged 18-55 years
• Skin phototype II, III and IV according to Fitzpatrick's classification (Fitzpatrick et al. 1974)
• Androgenetic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5, 5A, 5V (Hamilton, 1951)
• Willing and able to comply with scheduled visits
• Willing to maintain the same hair hygiene products and general hair care habits during the trial period
• Willing to maintain the same hair length and hair color during the trial period
• Willing to have treatment areas shaved for TrichoLAB® measurement and marked with small semi-permanent dot tattoos
• Willing to avoid prolonged UV exposition and UV tanning beds
• Signed written informed consent before participation in the trial.
• Subjects with a hair length of above 1 cm

You may not qualify if:

• 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
• 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
• 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
• History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
• Diabetes mellitus
• 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
• History or clinical signs of keloids or hypertrophic scars
• Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
• Current or within the last 6 months history of severe dietary or weight changes
• Hair transplantation at any time
• Known sensitization to cosmetic hair dyes or hypersensitivity to any ingredients of the IP or tattoo ink.
• 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.
• 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
• 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.
• Platelet rich plasma (PRP) or any mesotherapy treatment on scalp during the last 12 months as well as during the trial.

Sponsors & Collaborators

• Follicum AB: lead
• proDERM GmbH: collaborator
• Hair and Skin Institute, Charité, Berlin, Germany: collaborator
• CentroDerm GmbH: collaborator

Study Sites (1)

ProDerm GmbH

Hamburg, Germany

Location

MeSH Terms

Conditions

Alopecia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Ulrike Blume-Peytavi

  Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be conducted as a double-blind trial. Neither the Investigator nor the subject will know the identity of the IP assigned. Also, all other persons involved in the trial (e.g. Data Manager and Trial Statistician) remain blinded until all possible queries are resolved and 'closure of the data base' is done, i.e. after quality assurance of the data and hard lock of the data base clean files.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: June 24, 2020
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

DE (1)