| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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 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 antiandrogens may be an effective treatment for AGA. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Androgenetic alopecia (AGA) is scalp hair loss by male patients. Blocking or inhibiting the effect of specific androgens (hormones like testosterone) may be an effective treatment for AGA. |
|
| 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 | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10068558 |
| E.1.2 | Term | Androgenic alopecia |
| E.1.2 | System Organ Class | 100000004858 |
|
| 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 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. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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
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 that may have ancillary effect on hair
growth including, but not limited to, corticosteroids, pimecrolimus,
tacrolimus, and retinoids within four weeks of Visit 2/Baseline.
Scalp procedures (surgical, laser, light, or energy treatments, micro-
needling, etc.) within six months of Visit 2/Baseline;
Platelet rich plasma (PRP) procedure on the scalp at any time point.
14. Subject has used the following systemic medications or
procedures:
Beta blockers, cimetidine, diazoxide, or corticosteroids (including
intramuscular and intralesional injections) 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 four weeks prior to Visit 2/Baseline];
Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or
cyclosporine therapy within six months of Visit 2/Baseline.
• Finasteride (Propecia®, etc.) or similar product(s) within six months of Visit 2/Baseline.
• Dutasteride at any time point.
• Chemotherapy or cytotoxic agents within 12 months of Visit 2/Baseline;
• Radiation of the scalp at any time point;
• Other systemic therapy, which in the opinion of the investigator, may materially affect the subject’s hair or hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids.
15. Subject has been previously enrolled in AGA study with CB-03-01.
16. Subject is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor.
17. Subject has used or is suspected, in the investigator’s opinion, to be using anabolic steroids. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Co-primary efficacy end points include:
1. Change from Baseline in non-vellus TAHC at Month 12.
2. HGA score at Month 12. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
second efficacy:
1. Change from Baseline in non-vellus TAHC at Months 3, 6, and 9.
2. HGA score at Months 3, 6, and 9.
3. Changes from Baseline in non-vellus TAHW at Months 3, 6, 9, and
12.
4. Changes from Baseline in non-vellus TAHD at Months 3, 6, 9, and
12.
5. HGI and HGSS questionnaires at Months 3, 6, 9, and 12.
6. IGA at Months 3, 6, 9, and 12.
Safety endpoints include:
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. Changes from Baseline in vital signs and weight at Months 6, 12 and 13.
4. Changes from Screening in safety laboratory tests (chemistry,
hematology, urinalysis and morning cortisol) at Months 6, 12 and 13.
5. Changes from Screening in overall interpretation of the ECG at
Months 6, 12 and 13 (if applicable). |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | No |
| 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 |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| E.8.2.4 | Number of treatment arms in the trial | 5 |
| 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
|
| LVLS (last visit of the last subject) |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 18 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 18 |
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