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

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia; Hirsutism; Hypertrichosis
• Intervention / Treatment: Other: Placebo; Drug: FOL-005

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Virilism; Alopecia; Hirsutism; Hypertrichosis
• Other Study ID Numbers: FCS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided