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To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin

NCT03467412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-03

Study results available
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Summary

The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.

60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.

The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.

The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.

Conditions

  • Androgenic Alopecia

Interventions

DRUG

FOL-005

intradermal injection

DRUG

Placebo

intradermal injection

Sponsors & Collaborators

  • Bioskin GmbH

    collaborator INDUSTRY

  • Follicum AB

    lead INDUSTRY

Principal Investigators

  • Ulrike Blume-Peytavi, Professor · Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2018-08-22
Completion
2018-08-22

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467412 on ClinicalTrials.gov