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

Primary Purpose

Androgenic Alopecia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

FOL-005

Placebo

About this trial

This is an interventional treatment trial for Androgenic Alopecia

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Bioskin GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

0.00625 μg FOL-005

0.025 μg FOL-005

0.050 μg FOL-005

0.100 μg FOL-005

Placebo

Arm Description

50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.

50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.

50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.

50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.

50 μl solution (placebo) injected intradermally three times per week for 12 weeks.

Outcomes

Primary Outcome Measures

Scalp Hair Density

Change from baseline of total hair density (No. of hairs per cm"2") on the scalp

Secondary Outcome Measures

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.)

Change in Proportion of Telogen Hairs (%)

Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of

Anagen Hair Density

Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.

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.)

Full Information

NCT ID

NCT03467412

First Posted

March 5, 2018

Last Updated

December 2, 2020

Sponsor

Follicum AB

Collaborators

Bioskin GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03467412

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

August 22, 2018 (Actual)

Study Completion Date

August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Follicum AB

Collaborators

Bioskin GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenic Alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.00625 μg FOL-005

Arm Type

Experimental

Arm Description

50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.

Arm Title

0.025 μg FOL-005

Arm Type

Experimental

Arm Description

50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.

Arm Title

0.050 μg FOL-005

Arm Type

Experimental

Arm Description

50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.

Arm Title

0.100 μg FOL-005

Arm Type

Experimental

Arm Description

50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

50 μl solution (placebo) injected intradermally three times per week for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

FOL-005

Intervention Description

intradermal injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

intradermal injection

Primary Outcome Measure Information:

Title

Scalp Hair Density

Description

Change from baseline of total hair density (No. of hairs per cm"2") on the scalp

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Proportion of Anagen Hairs (%)

Description

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.)

Time Frame

From baseline to after 12 weeks treatment

Title

Change in Proportion of Telogen Hairs (%)

Description

Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of

Time Frame

From baseline to after 12 weeks treatment

Title

Anagen Hair Density

Description

Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.

Time Frame

From baseline to after 12 weeks treatment

Title

Change in Telogen Hair Density

Description

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.)

Time Frame

From baseline to after 12 weeks treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Blume-Peytavi, Professor

Organizational Affiliation

Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Bioskin GmbH

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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