| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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 5α-reductase into 5α-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.
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| E.1.1.1 | Medical condition in easily understood language |
| Female Androgenetic alopecia (AGA) is scalp hair loss which is due to a change in hormon concentrations which results in reduced hair growth and hair loss. |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10068558 |
| E.1.2 | Term | Androgenic alopecia |
| E.1.2 | System Organ Class | 100000004858 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The objective of this study is to evaluate the efficacy and safety of CB-03-01 solution 5%, 7.5% BID dosing compared to the Minoxidil solution 2% (BID) and the vehicle solution (BID) for the treatment of androgenetic alopecia in females. |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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).
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| E.4 | Principal 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. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline];
b) Retinoid, isotretinoin, vitamin A intake above 10,000 IU/day, or cyclosporine therapy within 6months of Visit 2/Baseline
c) Any 5 alpha reductase medications (i.e: Finasteride (Propecia®, etc), Dutasteride or similar products) within 12 months of Visit 2/Baseline
d) Chemotherapy or cytotoxic agents at any time
e) Radiation of the scalp at any time point
f) Anti-Androgens within 6 months Visit 2/Baseline; Anti-Androgens (cyproterone acetate, chlormadinone acetate, etc) together with contraceptive pills are allowed if use is stable [defined as doses and frequency unchanged for at least 3 months prior to Visit 2/Baseline]
g) Any changes in hormonal treatments for menopause during the 6 months prior to baseline or during the study
h) Other systemic therapy, which in the opinion of the investigator, may materially affect the subject’s hair or hair growth, including spironolactone, vitamin (including biotin intake >5mg/day) or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids during the 3 months prior to baseline or during the study
19. Subject has been previously enrolled in any study with CB 03 01
20. Subject is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Co-primary efficacy endpoints include:
1.CB-03-01 Treatment Effects in Change from Baseline in non-vellus TAHC at Month 6 in Comparison to Vehicle.
2.CB-03-01 Treatment Effects in HGA score at Month 6 in Comparison to Vehicle. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| months 6 (both co-primary endpoints) |
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| E.5.2 | Secondary end point(s) |
Efficacy:
1.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 in Comparison to Vehicle
2.CB-03-01 Treatment Effects in HGA score at Months 3 in Comparison to vehicle.
3.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 and 6 in Comparison to Minoxidil
4. CB-03-01 Treatment Effects in HGA score at Months 3 and 6 in Comparison to Minoxidil.
5.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHW at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
6.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHD at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
7. CB-03-01 Treatment Effects in HGI and HGSS scores at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
8. CB-03-01 Treatment Effects in IGA at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively
Cosmetic Evaluation:
1.Acceptability score
2.Easy to use score
Safety:
1.Incidence (severity and causality) of any local and systemic AEs
2.Number of subjects with presence (and severity) of the following reactions in the LTA: erythema, scaling, pruritus, burning/stinging, skin atrophy, telangiectasia, folliculitis, hypopigmentation, and hyperpigmentation at each time point
3.Number of subjects with presence (and severity) of Facial hypertrichosis
4.Changes from Baseline in vital signs and weight
5.Changes from Screening in overall interpretation of the ECG at Month 3, 6 and 7 (if applicable)
5.Changes from Screening in safety laboratory tests (chemistry, hematology, urinalysis, and morning cortisol)
6.Changes from Screening in overall interpretation of the ECG
PK Analysis:
Trough concentrations of CB-03-01
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy:
1 Months 3
2 Month 3
3 Months 3+6
4 Months 3+6
5 Months 3 + 6
6 Months 3 + 6
7 Months 3 + 6
8 Months 3 + 6
Cosmetic Evaluation:
1.Acceptability score:Month 1, 3 + 6
2.Easy to use score:Month 1, 3 + 6
Safety aspects (others at each timepoint/over the whole study duration):
Changes from Baseline in vital signs/weight:Months 3, 6 + 7
Changes from Screening in safety lab tests:Months 3, 6 + 7
Changes from Screening in overall interpretation of the ECG:Months 3, 6 + 7
PK:
Trough concentrations (CB-03-01):Month 3 + 6 |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
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