Clinical trial NCT02793557: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypertrichosis
Alopecia
Hirsutism
Lead sponsor: Follicum AB
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
timeFrame: 3 months
Secondary outcomes:
measure: Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2
timeFrame: 3 months
measure: Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs
timeFrame: 3 months
measure: Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Study officials:
affiliation: Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin
name: Ulrike Blume-Peytavi, Professor
role: PRINCIPAL_INVESTIGATOR
References: