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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers

Conditions
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Androgenic Alopecia

Intervention / Treatment
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* Drug: FOL-005
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.00625 μg FOL-005<br>50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks. | Drug: FOL-005<br>* intradermal injection<br>|
| Experimental: 0.025 μg FOL-005<br>50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks. | Drug: FOL-005<br>* intradermal injection<br>|
| Experimental: 0.050 μg FOL-005<br>50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks. | Drug: FOL-005<br>* intradermal injection<br>|
| Experimental: 0.100 μg FOL-005<br>50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks. | Drug: FOL-005<br>* intradermal injection<br>|
| Placebo Comparator: Placebo<br>50 μl solution (placebo) injected intradermally three times per week for 12 weeks. | Drug: Placebo<br>* intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp Hair Density | Change from baseline of total hair density (No. of hairs per cm2) on the scalp | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Anagen Hairs (%) | Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.) | From baseline to after 12 weeks treatment | 
| Change in Proportion of Telogen Hairs (%) | Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of | From baseline to after 12 weeks treatment | 
| Anagen Hair Density | Change from baseline of anagen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported. | From baseline to after 12 weeks treatment | 
| Change in Telogen Hair Density | Change from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.) | From baseline to after 12 weeks treatment |