Multi center clinical study to evaluate the safety and efficacy of CB-03-01 for the treatment of female pattern hair loss, versus Minoxidil and placebo at different dosage of CB-03-01

Phase 1

• Conditions: Female Androgenic Alopecia (AGA) 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 Anti-androgens may be an effective treatment for AGA.; MedDRA version: 21.1Level: LLTClassification code 10068558Term: Androgenic alopeciaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-000950-78-DE
• Lead Sponsor: Cassiopea S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

1.Subject is female, 18-55 years old.
2.Subject has provided written informed consent.
3.Negative pregnancy test at screening and baseline for women of childbearing potential (WOCBP)
4.Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved density area stages n. 3 to n. 6 on the Savin Density Scale.
5.Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study (implying the same hair coloring interval prior to the approved photos at screening/baseline)
6.Subject is willing to comply with study instructions and return to the clinic for required visits.
7.Subject agrees to continue her other general hair care products and regimen for the entire study.
8.Subject agrees to maintain same dietary and supplement pattern.
9. If subjects is sexually active with a male partner and is not surgically sterile or postmenopausal she must agree to use an acceptable form of birth control throughout the study and at least for one month after the end of treatment, as described in the informed consent form. An acceptable method (Pearl Index < 1%) would be:
-Use of hormonal contraceptives a minimum of 6 months prior to visit 2/baseline such as combined oral contraceptives (taking exclusion criterion 18f into account), hormonal implants, vaginal contraceptive ring and hormonal injections;
-Use of intrauterine devices;
-Subject is surgically sterile (hysterectomy, bilateral tubal ligation [at least six months prior], or bilateral oophorectomy).
Or being postmenopausal (defined as amenorrhea greater than 12 consecutive months in women).

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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Pregnancy or planned pregnancy
2.Breastfeeding women
3.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.
4.Subject has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of IMP or requires use of interfering topical, systemic, or surgical therapy.
5.Subject has a history or any signs of hyperandrogenemia
6.Subject has current/recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding.
7.Subject had scalp hair transplants at any time
8.Subject has a history or active hair loss due to diffuse telogen
effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA
9.Subject has a current or recent history (within 6 months) of severe dietary or weight changes or has a history of eating disorder(s) any history of bariatric surgery (gastric bypass, gastric sleeve, stomach stapling); macro- or micro-nutrient deficiencies within the last 6 months (i.e.: clinically significant iron deficiency, protein deficiency confirmed by lab testing) and/or any current diagnosis of malabsorptive disease (i.e Celiac, Irritable Bowel disease etc).
10.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 findings during the screening period
11.Subject with diagnosed treated or untreated hypertension and/ or with signs of or known clinically significant cardiovascular diseases or cardiac arrhythmia
12.Subject is currently enrolled in an investigational drug or device study
13.Subject has used an investigational drug or investigational device treatment within 30 days or 5 half-lives (whichever is longer)prior to Visit 2/Baseline.
14.Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
15.Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, subjects who are unable to return for scheduled follow-up visits, or subjects who are institutionalized because of legal or regulatory order
16.Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink
17.Subject has used any of the following topical preparations or procedures on the scalp:
a)Topical scalp treatments for hair growth or other agents known to affect hair growth within 12weeks of Visit 2/Baseline;
b)Topical scalp over-the-counter or cosmetic treatments known or reasonably believed to affect hair growth/health or hair growth products with saw palmetto, copper, etc. within 4weeks of Visit 2/Baseline
c)Topical scalp treatments that may have ancillary effect on hair growth (e.g.corticosteroids, retinoids) within 4weeks of Visit 2/Baseline
d)Scalp procedures within 6 months of Visit 2/Baseline;
e)Platelet rich plasma (PRP) procedure on the scalp within 1 year
18.Subject has used the following systemic medications/procedures:
a)Beta blockers, cimetidine, diazoxide, or corticosteroids within 12 weeks of Visit 2/Baseline. Inha

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified