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Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth

Primary Purpose

Hypertrichosis, Alopecia, Hirsutism

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

FOL-005

Placebo

About this trial

This is an interventional treatment trial for Hypertrichosis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male, aged 18-45 years
Clinically visible terminal hair growth on thighs

Exclusion Criteria:

Damaged skin in or around test sites
History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial
History or clinical signs of keloids or hypertrophic scars
Immunological disorders such as alopecia areata, and systemic lupus erythematosus
Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants)
Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks
Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens
Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors
Current or within one week prior to first dosing use of any topical drugs on the legs

Sites / Locations

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

FOL-005: Solution 1

FOL-005: Solution 2

FOL-005: Solution 3

FOL-005: Solution 4

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Outcomes

Primary Outcome Measures

Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects

Secondary Outcome Measures

Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2

Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs

Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs

Full Information

NCT ID

NCT02793557

First Posted

May 16, 2016

Last Updated

July 29, 2017

Sponsor

Follicum AB

1. Study Identification

Unique Protocol Identification Number

NCT02793557

Brief Title

Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth

Official Title

A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Follicum AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.

Detailed Description

SAD part: A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3. MD part: In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.

6. Conditions and Keywords

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

Hypertrichosis, Alopecia, Hirsutism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.

Arm Title

FOL-005: Solution 1

Arm Type

Experimental

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Arm Title

FOL-005: Solution 2

Arm Type

Experimental

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Arm Title

FOL-005: Solution 3

Arm Type

Experimental

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Arm Title

FOL-005: Solution 4

Arm Type

Experimental

Arm Description

Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.

Intervention Type

Drug

Intervention Name(s)

FOL-005

Intervention Description

Intradermal injection of 50 μl solution

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2

Time Frame

3 months

Title

Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs

Time Frame

3 months

Title

Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs

Time Frame

3 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male, aged 18-45 years Clinically visible terminal hair growth on thighs Exclusion Criteria: Damaged skin in or around test sites History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial History or clinical signs of keloids or hypertrophic scars Immunological disorders such as alopecia areata, and systemic lupus erythematosus Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants) Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors Current or within one week prior to first dosing use of any topical drugs on the legs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Blume-Peytavi, Professor

Organizational Affiliation

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth

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