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

NCT02793557 | Completed Phase 1

• 1 other identifier: FCS-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrichosis; Alopecia; Hirsutism

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (3)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

FOL-005: Solution 1

EXPERIMENTAL

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

FOL-005: Solution 2

EXPERIMENTAL

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

FOL-005: Solution 3

EXPERIMENTAL

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

FOL-005: Solution 4

EXPERIMENTAL

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

Interventions

FOL-005 DRUG

Intradermal injection of 50 μl solution

FOL-005: Solution 1; FOL-005: Solution 2; FOL-005: Solution 3; FOL-005: Solution 4

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Follicum AB: lead

Study Sites (1)

Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Hypertrichosis; Alopecia; Hirsutism

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Virilism; Signs and Symptoms

Study Officials

• Ulrike Blume-Peytavi, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: June 8, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

DE (1)