A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss

NCT05910450 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CB-03-01/37
• Study Type: interventional
• Target: 703
• Locations: 2 countries
• Sites: 24

Brief Summary

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below.

• They will be asked about their previous medical history and current medications.
• A brief physical examination will be performed.
• Vital signs, weight and height will be measured.
• Electrocardiograms will be performed.
• Subject's scalp will be checked for any signs of irritation.
• Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness).
• Blood draws and urine sample collection for safety laboratory tests.
• Subject will be asked to complete, on site, the following two questionnaires:
• Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use.
• Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

Conditions

Alopecia, Androgenetic

Keywords

Alopecia; Androgenetic; Clascoterone solution; Phase 3; Randomized; Double-blind; Vehicle-controlled; AGA

Outcome Measures

Primary Outcomes (2)

• Changes in non-vellus Total Area Hair Count (TAHC)

  Changes from Pivotal Part 1 Baseline in non-vellus Total Area Hair Count (TAHC) at Month 6.

  6 months

• Subject's assessment of own hair coverage

  MAA-PRO item 8, a hair coverage-specific PGI-C, as the co-primary endpoint. The clinically meaningful change (threshold) is defined as a response of "1", "2", or "3". Note that the item 2 responder threshold was used as a criterion for subjects to qualify for Part 2 enrollment.

  6 months

Secondary Outcomes (2)

• Changes in non-vellus TAHC

  3 months

• Changes in subject's assessment of satisfaction score

  6 months

Study Arms (4)

Clascoterone Part 1 and Part 2

EXPERIMENTAL

Subjects treated for 12 months with Clascoterone 5% solution (both in double-blind Part 1 and in the single-blind Part 2 of the study)

Drug: Clascoterone 5% solution

Clascoterone Part 1 + Vehicle Part 2

OTHER

Subjects treated for the first 6 months Part 1 in double-blind with Clascoterone 5% solution followed by 6 months Part 2 in the single-blind label with Vehicle

Drug: Clascoterone 5% solution; Drug: Vehicle solution

Vehicle Part 1 + Clascoterone Part 2

OTHER

Subjects treated for the first 6 months Part 1 in double-blind with Vehicle followed by 6 months Part 2 in the single-blind label with Clascoterone 5% solution.

Drug: Clascoterone 5% solution; Drug: Vehicle solution

Vehicle Part 1 and Part 2

PLACEBO COMPARATOR

Subjects treated for 12 months with Vehicle (both in double-blind Part 1 and in the single-blind Part 2 of the study)

Drug: Vehicle solution

Interventions

Clascoterone 5% solution DRUG

Topical application of 1.5 ml of clascoterone solution 5%, twice a day, to balding areas of the scalp (vertex and temples)

Also known as: CB-03-01 5% solution

Clascoterone Part 1 + Vehicle Part 2; Clascoterone Part 1 and Part 2; Vehicle Part 1 + Clascoterone Part 2

Vehicle solution DRUG

Topical application of 1.5 ml of vehicle, twice a day, to balding areas of the scalp (vertex and temples)

Also known as: Vehicle

Clascoterone Part 1 + Vehicle Part 2; Vehicle Part 1 + Clascoterone Part 2; Vehicle Part 1 and Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject can participate in this clinical study if all the following criteria are met:
• 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).

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible to participate in the study:
• 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:

Sponsors & Collaborators

• Cassiopea SpA: lead
• Ergomed PLC: collaborator
• Pharmapace Inc: collaborator
• Canfield Scientific Inc.: collaborator
• ICON Clinical Research: collaborator

Study Sites (24)

The Petrus Center for Aesthetic Surgery and Hair Transplantation

North Little Rock, Arkansas, 72116, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Mayo Clinic, Department of Dermatology

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Diane S. Berson MD, PLLC

New York, New York, 10022, United States

Location

Derm Research Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

On Site Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

DelRicht Research

Frisco, Texas, 75034, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

LTD Health

Batumi, 6000, Georgia

Location

JSC Curatio

Tbilisi, 0114, Georgia

Location

Kanveni National Center of Dermatology and Venerology

Tbilisi, 0159, Georgia

Location

Tbilisi Cancer Center

Tbilisi, 0159, Georgia

Location

Aversi Clinic

Tbilisi, 0160, Georgia

Location

Medi Club

Tbilisi, 0160, Georgia

Location

David Abuladze Georgian-Italian Clinic

Tbilisi, 0179, Georgia

Location

LTD "Medinvestment"

Tbilisi, 0186, Georgia

Location

MeSH Terms

Conditions

Alopecia

Interventions

Clascoterone; Solutions

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Alessandro Mazzetti, M.D.

  Cassiopea SpA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal, Double-Blind - Part 1: multicenter, prospective, randomized, Double Blind, vehicle-controlled interventional study. Extension, Single-Blind - Part 2: subjects who will have completed Pivotal, Double-Blind - Part I of the trial and have been defined as Part 1 responders, will be randomized to be treated, in Single-Blind, for additional 6 months with IMP or vehicle solution.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 18, 2023
• Study Start: June 21, 2023
• Primary Completion: January 26, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

GE (8); US (16)