A Phase 2a, multi-center, prospective trial with random assignments to treatment Groups. The Trial is double-blind, vehicle controlled and dose ranging. The aim ist to evaluate the efficacy and safety of CB-03-01 solution for the Treatment with male pattern baldness.
- Conditions
- AGA (androgenic alopecia) is scalp hair loss that occurs due to an underlying susceptibility of hair follicles to androgenic miniaturization. In the hair follicle, testosterone is converted by 5a-reductase into 5a-dihydrotestosterone (DHT). The DHT level is increased in the balding scalp and may be the more relevant androgen for AGA pathogenesis. Thus, blocking or inhibiting the effect of DHT with the local application of antiandrogens may be an effective treatment for AGA.MedDRA version: 20.0 Level: LLT Classification code 10068558 Term: Androgenic alopecia System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-003733-23-DE
- Lead Sponsor
- Cassiopea S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
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
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
atrophy.
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
study.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to evaluate the efficacy and safety of CB-03-01 solution, 2.5%, 5.0%, 7.5% BID dosing and 7.5% QD dosing compared to vehicle for the treatment of AGA in males.;Secondary Objective: n.a.;<br> Primary end point(s): Co-primary efficacy end points include:<br> 1. Change from Baseline in non-vellus TAHC at Month 12.<br> 2. HGA score at Month 12.<br> ;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method