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Clinical Trials/EUCTR2016-003733-23-DE
EUCTR2016-003733-23-DEActive, not recruitingPhase 1

A PHASE 2, MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CB 03 01 (CORTEXOLONE 17a-PROPIONATE) SOLUTION FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES

Cassiopea S.p.A.0 sites400 target enrollmentStarted: January 5, 2017Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
400
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Subject is male, 18-55 years old.
  • •2. Subject has provided written informed consent.
  • •3. Subject has mild to moderate AGA in temple and vertex region,
  • •rating III vertex to V on the Modified Norwood-Hamilton Scale (i.e.,
  • •IIIv, IV, or V), with a history of ongoing hair loss.
  • •4. Subject is willing to maintain the same hairstyle, hair length, and
  • •hair color throughout the study.
  • •5. Subject is willing to comply with study instructions and return to
  • •the clinic for required visits.
  • •6. Subject agrees to continue his other general hair care products and
  • •regimen for the entire study.
  • •7. Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index < 1%) would be to agree to use implants, injectables, combined oral contraceptives, some intrauterine devices, or be postmenopausal (defined as amenorrhea greater than 12 consecutive months in women 50 years of age or older), be surgically sterile (hysterectomy, bilateral tubal ligation [at least six months prior], or bilateral oophorectomy). For males, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception.
  • •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 400
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Subject has any dermatological disorders of the scalp in the target
  • •region with the possibility of interfering with the application of the
  • •IMP or examination method, such as fungal or bacterial infections,
  • •seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp
  • •2. Subject has any skin pathology or condition that, in the
  • •investigator’s opinion, could interfere with the evaluation of the
  • •IMP or requires use of interfering topical, systemic (e.g.,
  • •uncontrolled thyroid disease, certain genetic disorders that involve
  • •hair growth or patterns), or surgical therapy.
  • •3. Subject has current or recent history (within 12 months) of hair
  • •weaves, non-breathable wigs, or hair bonding.
  • •4. Subject had scalp hair transplants at any time.
  • •5. Subject has a history or active hair loss due to diffuse telogen
  • •effluvium, alopecia areata, scarring alopecia, trichotillomania, or
  • •conditions/diseases other than AGA.
  • •6. Subject has a current or recent history (within six months) of
  • •severe dietary or weight changes or has a history of eating
  • •disorder(s); if such has resulted in hair loss refer to exclusion
  • •criterion #5.
  • •7. Subject has any condition which, in the investigator’s opinion,
  • •would make it unsafe for the subject to participate in this study,
  • •including clinically significant abnormal laboratory or 12-lead
  • •electrocardiogram (ECG) findings during the screening period.
  • •8. Subject is currently enrolled in an investigational drug or device
  • •9. Subject has used an investigational drug or investigational device
  • •treatment within 30 days prior to Visit 2/Baseline.
  • •10. Subject is unable to communicate or cooperate with the
  • •investigator due to language problems, poor mental development,
  • •or impaired cerebral function.
  • •11. Subject may be unreliable for the study including subjects who
  • •engage in excessive alcohol intake or drug abuse, or subjects who
  • •are unable to return for scheduled follow-up visits.
  • •12. Subject has a known hypersensitivity or previous allergic reaction
  • •to any of the active or inactive ingredients in the IMPs or tattoo ink.
  • •13. Subject has used any of the following topical preparations or
  • •procedures on the scalp:
  • •?Topical scalp treatments for hair growth including minoxidil,
  • •hormone therapy, anti-androgens, or other agents that are known
  • •to affect hair growth within 12 weeks of Visit 2/Baseline;
  • •?Topical scalp over-the-counter (OTC) or cosmetic treatments
  • •known or reasonably believed to affect hair growth (e.g., brands
  • •such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or
  • •hair growth products with saw palmetto, copper, etc. within four
  • •weeks of Visit 2/Baseline;
  • •? Topical scalp treatments

Investigators

Sponsor
Cassiopea S.p.A.

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