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Clinical Trials/EUCTR2017-003809-17-DE
EUCTR2017-003809-17-DE
Active, not recruiting
Phase 1

A randomised, double-blind, placebo-controlled phase 2 trial of FOL-005 to investigate efficacy on hair growth on scalp skin in healthy volunteers.

Follicum AB0 sites60 target enrollmentNovember 9, 2017
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Follicum AB
Enrollment
60
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 9, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Healthy male, aged 18\-55 years
  • •2\.Androgenetic alopecia (AGA)) – Norwood/Hamilton grade 3V to 4/4a
  • •3\.Caucasian, skin type I – IV according to Fitzpatrick’s classification
  • •4\.Willing to have treatment areas shaved for TrichoScan® measurement marked with small semi\-permanent dot tattoos
  • •5\.Willing to maintain the same hygiene products and skin cleansing habits during the trial period.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 60
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •1\.Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test sites risking interfering with investigational evaluations
  • •2\.Any dermatological disorders of the scalp or skin pathology which might interfere with the application of IMP or examination method
  • •3\.History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
  • •4\.History of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria) or known skin cancer that in the opinion of the investigators might confound the results of the trial
  • •5\.Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
  • •6\.Diabetes mellitus
  • •7\.Coagulation deficiencies
  • •8\.Known or suspected allergy or sensitization to cosmetic hair dyes or hypersensitivity to ingredients of the IMP or tattoo ink.
  • •9\.Any topical or systemic treatments with agents, known or suspected to affect hair growth
  • •10\.Use of or planned use of any shampoo with expected medicinal effect on the scalp (e.g. but not limited to antifungal or anti\-dandruff shampoo, shampoo containing urea, caffeine or acetylsalicylic acid, etc.) during the course of the trial

Outcomes

Primary Outcomes

Not specified

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