To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin

NCT ID: NCT03467412

Last Updated: 2020-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2018-08-22

Brief Summary

The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.

60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.

The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.

The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.00625 μg FOL-005

50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

intradermal injection

0.025 μg FOL-005

50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

intradermal injection

0.050 μg FOL-005

50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

intradermal injection

0.100 μg FOL-005

50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.

Group Type: EXPERIMENTAL

FOL-005

Intervention Type: DRUG

intradermal injection

Placebo

50 μl solution (placebo) injected intradermally three times per week for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

intradermal injection

Interventions

FOL-005

intradermal injection

Intervention Type: DRUG

Placebo

intradermal injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male, aged 18-55 years
• Androgenetic alopecia (AGA)) - Norwood/Hamilton grade 3V to 4/4a
• Caucasian, skin type I - IV according to Fitzpatrick's classification

Exclusion Criteria

• Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis 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 treatment areas or requires topical or systemic therapy
• History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
• Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
• Diabetes mellitus
• Coagulation deficiencies
• Topical treatments for hair growth (minoxidil, anti-androgens or other agents known to affect hair growth) in the last 6 months
• Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids in the last 2 months or other treatments that may affect hair growth
• Platelet rich plasma (PRP) treatment on scalp during the last 12 months
• Systemic therapy using retinoids, cyclosporine within the last 3 months
• Systemic treatment with beta blockers or corticosteroids, scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months
• Finasteride (e.g. Propecia®) or Dutasteride intake in the last 12 months, or any systemic hair therapy medication in the last 12 months
• History of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria) or 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
• Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening
• Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifylline, nitroglycerine) or anticoagulating drugs (e.g. heparins, cumarins, new oral anticoagulants, regular intake of acetylsalicylic acid)
• Current or within 3 months prior to first dosing use of anti-inflammatory medication (ibuprofen, paracetamol is permitted), corticosteroids (nose drops, eye drops and/or inhalers are permitted) or immunosuppressive drugs taken for more than 2 consecutive weeks
• Hair transplantation at any time

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bioskin GmbH

INDUSTRY

Sponsor Role: collaborator

Follicum AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrike Blume-Peytavi, Professor

Role: PRINCIPAL_INVESTIGATOR

Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

Locations

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Berlin, , Germany

Bioskin GmbH

Hamburg, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-003809-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FCS-002

Identifier Type: -

Identifier Source: org_study_id