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

NCT03467412 | Completed Phase 2 Results

• 2 other identifiers: FCS-0022017-003809-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Scalp Hair Density

  Change from baseline of total hair density (No. of hairs per cm"2") on the scalp

  12 weeks

Secondary Outcomes (4)

• Proportion of Anagen Hairs (%)

  From baseline to after 12 weeks treatment

• Change in Proportion of Telogen Hairs (%)

  From baseline to after 12 weeks treatment

• Anagen Hair Density

  From baseline to after 12 weeks treatment

• Change in Telogen Hair Density

  From baseline to after 12 weeks treatment

Study Arms (5)

0.00625 μg FOL-005

EXPERIMENTAL

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

Drug: FOL-005

0.025 μg FOL-005

EXPERIMENTAL

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

Drug: FOL-005

0.050 μg FOL-005

EXPERIMENTAL

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

Drug: FOL-005

0.100 μg FOL-005

EXPERIMENTAL

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

Drug: FOL-005

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

FOL-005 DRUG

intradermal injection

0.00625 μg FOL-005; 0.025 μg FOL-005; 0.050 μg FOL-005; 0.100 μg FOL-005

Placebo DRUG

intradermal injection

Placebo

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Follicum AB: lead
• Bioskin GmbH: collaborator

Study Sites (2)

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

Bioskin GmbH

Hamburg, 20095, Germany

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: CEO Jan Alenfall
• Organization: Follicum AB

jan.alenfall@follicum.com

+46 (0)70 931 51 15

Study Officials

• Ulrike Blume-Peytavi, Professor

  Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 16, 2018
• Study Start: February 27, 2018
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-09

Locations

DE (2)