Status:
COMPLETED
To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
Lead Sponsor:
Follicum AB
Collaborating Sponsors:
Bioskin GmbH
Conditions:
Androgenic Alopecia
Eligibility:
MALE
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03467412
Start Date
February 27 2018
End Date
August 22 2018
Last Update
December 3 2020
Active Locations (2)
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1
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, Germany, 10117
2
Bioskin GmbH
Hamburg, Germany, 20095