Evaluation of Clascoterone Solution Efficacy and Safety in Androgenetic Alopecia Treatment in Adult Males: A Phase 3 Randomized Double-Blind Study

Trial ID: 2023-504421-39-00
Protocol: CB-03-01/38
Sponsor: Cassiopea S.p.A.

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Diseases & Conditions

Androgenetic alopecia

Objectives

The primary objective of this study is to evaluate the **efficacy** and **safety** of Clascoterone solution, administered twice daily (BID), compared to a vehicle solution for the treatment of **androgenetic alopecia** in adult males over a 6-month period. This objective is clinically relevant as androgenetic alopecia, commonly known as male pattern hair loss, is a prevalent condition that can significantly impact quality of life. The study aims to determine whether Clascoterone, a steroidal antiandrogen for topical use, can effectively promote hair growth and improve patient outcomes compared to a placebo.

Participants

The clinical trial involves a total of **300 participants**, specifically targeting adult males aged **18 years and older** diagnosed with **androgenetic alopecia**. The study population was selected based on specific criteria, including males with mild to moderate androgenetic alopecia in the temple and vertex regions, classified as III vertex to V on the Modified Norwood-Hamilton Scale. Participants are required to maintain consistent hairstyle, hair length, and hair color throughout the study duration. Additionally, they must adhere to their existing shampoo frequency and general hair care regimen, as well as maintain their dietary and supplement patterns. The trial excludes female subjects and does not involve any vulnerable populations. Participants were selected based on their willingness to comply with study instructions and attend required clinic visits. The study does not include any female participants, and the trial population is not considered vulnerable. Key lifestyle considerations include maintaining consistent hair care and dietary habits throughout the study period.

Plans and Procedures

The clinical trial is a **randomized**, **double-blind**, vehicle-controlled study designed to evaluate the efficacy and safety of topically applied **Clascoterone Solution** for the treatment of **androgenetic alopecia** in males. The trial is structured in two parts: an initial 6-month double-blind phase followed by a 6-month single-blind treatment phase. The primary objective of the first phase is to compare the efficacy and safety of Clascoterone Solution with a vehicle solution, both administered twice daily (BID). The trial is expected to conclude by March 31, 2025, with recruitment starting on October 30, 2023.

Participants will undergo a series of study visits, beginning with a screening visit to confirm eligibility based on specific inclusion criteria, such as being male, aged 18 or older, and having mild to moderate androgenetic alopecia. Following successful screening, participants will be randomized to receive either the Clascoterone Solution or the vehicle solution. Study visits will occur at regular intervals to monitor safety, adherence, and efficacy, with assessments including changes in non-vellus terminal area hair count (TAHC) and participant self-assessment of hair coverage. The primary endpoints will be evaluated at the 6-month mark of the double-blind phase.

The expected duration of participant involvement is approximately 12 months, encompassing both the double-blind and single-blind phases. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events, or withdrawal of consent. Participants are required to maintain consistent hair care routines and lifestyle habits throughout the study to ensure the reliability of results. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure participant safety and data integrity.

Treatment

The clinical trial involves the use of **Clascoterone Solution**, a **steroidal antiandrogen** formulated as a **cutaneous solution**. The active substance, **clascoterone**, is of chemical origin and is administered via **topical administration**. The solution is applied twice daily (BID) for the treatment of **androgenetic alopecia** in adult males. The maximum daily dose is 150 mg, with a total maximum dose of 55.05 mg over a treatment period of up to 367 days. The product is identified by the sponsor product code CB-03-01 and is manufactured by Cassiopea S.P.A.

The study also includes a **vehicle solution** as a comparator treatment, serving as a placebo control. The vehicle solution does not contain any active pharmaceutical ingredients and is used to evaluate the efficacy and safety of the Clascoterone Solution by comparison. The vehicle solution is administered in the same manner as the Clascoterone Solution, applied topically twice daily. This approach ensures that any observed effects can be attributed to the active treatment rather than the application process itself.

Efficacy

The efficacy of Clascoterone Solution in the treatment of **androgenetic alopecia** in males will be assessed through a 6-month, multicenter, prospective, randomized, double-blind, vehicle-controlled study. The primary efficacy endpoints include changes from the baseline in non-vellus terminal area hair count (TAHC) at Month 6, and the subject's assessment of their own hair coverage at Month 6, defined as the proportion of MAA-PRO core measure item 2 responders. Secondary efficacy endpoints involve changes from the baseline in non-vellus TAHC at Month 3 and changes in the MAA-PRO SI single treatment satisfaction item score at Month 6.

Efficacy parameters will be measured and collected at specified timepoints, including baseline, Month 3, and Month 6. The analysis will focus on the comparison between the Clascoterone solution and the vehicle solution, both applied twice daily (BID). The study will utilize validated scales and patient-reported outcomes to ensure accurate and reliable data collection. The trial is designed to provide robust evidence on the efficacy of Clascoterone Solution in improving hair coverage and satisfaction among participants with androgenetic alopecia.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Subject who is male ≥18 years old.
Subject who has provided written informed consent.
Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to V on the Modified Norwood-Hamilton Scale (i.e., III vertex [IIIv], IV, or V), with a history of ongoing hair loss.
Subject who is willing to maintain the same hairstyle, hair length and hair color throughout the study.
Subject who is willing to comply with study instructions at home and return to the clinic for required visits.
Subject who agrees to continue his shampoo frequency and other general hair care products and regimen for the entire study.
Subject who agrees to maintain same dietary and supplement pattern.
Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to use an acceptable form of birth control as described in the informed consent form. For subjects, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception. 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 6 months prior], or bilateral oophorectomy).

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Exclusion Criteria

Subject who 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.
Subject who 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.
Subject who has current or recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding.
Subject who had scalp hair transplants at any time.
Subject with a history of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
Subject who 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.).
Subject who has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this study, including 12-lead electrocardiogram (ECG) findings during the screening period.
Subject is currently enrolled in an investigational drug or device study.
Subject who has used an investigational drug or investigational device treatment within 30 days or 5 half-lives whichever is longer prior to Visit 2/Baseline.
Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject who has used or is suspected, in the investigator’s opinion, to be using anabolic steroids.
Subject who may be unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, and/or subjects who will be unable to return for scheduled follow-up visits.
Subject who has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink.
Subject who has used any of the following topical preparations or procedures on the scalp: a) Topical scalp treatments for hair growth including minoxidil, Aminexil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of Visit 2/Baseline. b) Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within 2 weeks of Visit 2/Baseline. c) Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within 4 weeks of Visit 2/Baseline. d) Scalp procedures (surgical, laser, light, or energy treatments, micro- needling, etc.) within 6 months of Visit 2/Baseline. e) Platelet rich plasma (PRP) procedure on the scalp within 6 months of Visit 2/Baseline.
Subject who has used one or more of the following systemic medications or procedures: a) 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 4 weeks prior to Visit 2/Baseline]. b) Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline. c) Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.], Dutasteride or similar products within 6 months of Visit 2/Baseline. d) Chemotherapy or cytotoxic agents at any time. e) Radiation of the scalp at any time point. f) 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, spironolactone, vitamin 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.
Subject who has been previously enrolled in any study with Clascoterone (former CB-03-01).
Subject who is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor.
Subject who is institutionalized because of legal or regulatory order.