ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03467412
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Bioskin GmbH
Information provided by (Responsible Party):
Follicum AB

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Androgenic Alopecia Drug: FOL-005 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.00625 μg FOL-005
0.00625 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Drug: FOL-005
intradermal injection

Experimental: 0.025 μg FOL-005
0.025 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Drug: FOL-005
intradermal injection

Experimental: 0.050 μg FOL-005
0.050 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Drug: FOL-005
intradermal injection

Experimental: 0.100 μg FOL-005
0.100 μg FOL-005, solution. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Drug: FOL-005
intradermal injection

Placebo Comparator: Placebo
Placebo. 50 μl injected sub-cutaneous three times per week for 12 weeks.
Drug: Placebo
intradermal injection




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467412


Locations
Germany
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, Germany, 10117
Bioskin GmbH
Hamburg, Germany, 20095
Sponsors and Collaborators
Follicum AB
Bioskin GmbH

Responsible Party: Follicum AB
ClinicalTrials.gov Identifier: NCT03467412     History of Changes
Other Study ID Numbers: FCS-002
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical