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

Sponsor

Follicum AB (Industry)

Overall Status

Completed

CT.gov ID

NCT02793557

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrichosis Alopecia Hirsutism	Drug: FOL-005 Other: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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.	Other: Placebo
Experimental: FOL-005: Solution 1 Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.	Drug: FOL-005 Intradermal injection of 50 μl solution
Experimental: FOL-005: Solution 2 Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.	Drug: FOL-005 Intradermal injection of 50 μl solution
Experimental: FOL-005: Solution 3 Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.	Drug: FOL-005 Intradermal injection of 50 μl solution
Experimental: FOL-005: Solution 4 Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.	Drug: FOL-005 Intradermal injection of 50 μl solution

Outcome Measures

Primary Outcome Measures

Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects [3 months]

Secondary Outcome Measures

Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2 [3 months]
Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs [3 months]
Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin	Berlin		Germany	10117

Sponsors and Collaborators

Follicum AB

Investigators

Principal Investigator: Ulrike Blume-Peytavi, Professor, Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Follicum AB

ClinicalTrials.gov Identifier:

NCT02793557

Other Study ID Numbers:

FCS-001

First Posted:

Jun 8, 2016

Last Update Posted:

Aug 1, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Alopecia

Hirsutism

Hypertrichosis

Study Results

No Results Posted as of Aug 1, 2017