A study to investigate if use of FOL-005 can increase hair growth.

Phase 1

• Conditions: Alopecia.; MedDRA version: 20.0 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003809-17-DE
• Lead Sponsor: Follicum AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Healthy male, aged 18-55 years
2.Androgenetic alopecia (AGA)) – Norwood/Hamilton grade 3V to 4/4a
3.Caucasian, skin type I – IV according to Fitzpatrick’s classification
4.Willing to have treatment areas shaved for TrichoScan® measurement marked with small semi-permanent dot tattoos
5.Willing to maintain the same hygiene products and skin cleansing habits during the trial period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 interfering with investigational evaluations
2.Any dermatological disorders of the scalp or skin pathology which might interfere with the application of IMP or examination method
3.History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
4.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
5.Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
6.Diabetes mellitus
7.Coagulation deficiencies
8.Known or suspected allergy or sensitization to cosmetic hair dyes or hypersensitivity to ingredients of the IMP or tattoo ink.
9.Any topical or systemic treatments with agents, known or suspected to affect hair growth
10.Use of or planned use of any shampoo with expected medicinal effect on the scalp (e.g. but not limited to antifungal or anti-dandruff shampoo, shampoo containing urea, caffeine or acetylsalicylic acid, etc.) during the course of the trial
11.Elevated values for vital signs:
•blood pressure: systolic above 160 mmHg, diastolic above 95 mmHg
•heart rate: above 100 beats/min.
12.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)
13.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
14.Current or within the last 6 months history of severe dietary or weight changes
15.Hair transplantation at any time

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified