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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03467412
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : April 10, 2018
Bioskin GmbH
Information provided by (Responsible Party):
Follicum AB

March 5, 2018
March 16, 2018
April 10, 2018
March 5, 2018
August 30, 2018   (Final data collection date for primary outcome measure)
To evaluate the efficacy of FOL-005 on scalp hair density [ Time Frame: 12 weeks ]
Change from baseline of total hair density (No. of hairs per cm2) on the scalp
Same as current
Complete list of historical versions of study NCT03467412 on Archive Site
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To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers

The trial is 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 will be eligible for inclusion.

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

The effect on hair growth will be measured at week 8 and 12

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Androgenic Alopecia
  • Drug: FOL-005
    intradermal injection
  • Drug: Placebo
    intradermal injection
  • Experimental: 0.00625 μg FOL-005
    Intervention: Drug: FOL-005
  • Experimental: 0.025 μg FOL-005
    Intervention: Drug: FOL-005
  • Experimental: 0.050 μg FOL-005
    Intervention: Drug: FOL-005
  • Experimental: 0.100 μg FOL-005
    Intervention: Drug: FOL-005
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 30, 2018
August 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Contact: Jan Alenfall, PhD +46 (0)46 19 21 97
Contact: Johan Quensel, PhD +46 760466744
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Follicum AB
Follicum AB
Bioskin GmbH
Not Provided
Follicum AB
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP