A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (SCALP2)

February 9, 2024 updated by: Cassiopea SpA

A 6-month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-month Single-Blind Treatment With Clascoterone or Vehicle Solution

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

726

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10629
        • Recruiting
        • emovis GmbH
        • Contact:
          • Guido Burbach, MD
        • Contact:
      • Berlin, Germany, 10117
        • Recruiting
        • Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin
        • Contact:
          • Ulrike Blume-Peytavi, MD
        • Contact:
      • Düsseldorf, Germany, 40212
        • Recruiting
        • Privatpraxis Dr. Hilton & Partner
        • Contact:
          • Rodrigo da Mota
        • Contact:
      • Freiburg, Germany, 79098
        • Recruiting
        • Dermaticum-Privatpraxis für Dermatologie
        • Contact:
          • Rolf Hoffmann, MD
        • Contact:
      • Hamburg, Germany, 20095
      • Mainz, Germany, 55131
        • Recruiting
        • Department of Dermatology and Allergy, Johannes Gutenberg-Universität KöR
        • Contact:
          • Petra Staubach, MD
        • Contact:
  • Poland
      • Katowice, Poland, 40-611
        • Recruiting
        • Centrum Medyczne Angelius Provita
        • Contact:
          • Magdalena Kolanko, MD
        • Contact:
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia
        • Contact:
          • Kamila Płaczek, MD
        • Contact:
      • Krakow, Poland, 30-033
        • Recruiting
        • Centrum Medyczne All-med Badania Kliniczne
        • Contact:
          • Grażyna Pulka, MD
        • Contact:
      • Kraków, Poland, 31-011
        • Recruiting
        • Centrum Nowoczesnych Terapii Dobry Lekarz
        • Contact:
          • Malgorzata Dyczek, MD
        • Contact:
      • Kraków, Poland, 31-559
        • Recruiting
        • Diamond Clinic Sp. z o.o.
        • Contact:
          • Barbara Rewerska, MD
        • Contact:
      • Lublin, Poland, 20-412
        • Recruiting
        • Pro Life Medica
        • Contact:
          • Agnieszka Sajdak-Wojtaluk, MD
        • Contact:
      • Warszawa, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii iRehabilitacji im. prof. dr hab. med. Eleonory Reicher
        • Contact:
          • Mariusz Sikora, MD
        • Contact:
      • Warszawa, Poland, 02-661
        • Recruiting
        • Carpe Diem Centrum Medycyny Estetycznej
        • Contact:
          • Weronika Mołga, MD
        • Contact:
      • Łódź, Poland, 90-436
        • Not yet recruiting
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan, J.Narbutt, A. Lesiak
        • Contact:
          • Aleksandra Lesiak, MD
        • Contact:
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
    • Florida
      • Hollywood, Florida, United States, 33021
        • Not yet recruiting
        • Physician's Institute of Cosmetic and Reconstructive Surgery
        • Contact:
          • Jonathan Weiser, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Delricht Research
        • Contact:
          • Robert Springer, MD
        • Contact:
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute
        • Contact:
          • Ali Moiin, MD
        • Contact:
      • Warren, Michigan, United States, 48088
        • Not yet recruiting
        • Grekin Skin Institute
        • Contact:
          • Steven Grekin, MD
        • Contact:
    • Missouri
      • Wildwood, Missouri, United States, 63040
        • Recruiting
        • Delricht Research
        • Contact:
        • Contact:
          • Christopher Kling, MD
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Piedmont Plastic Surgery and Dermatology
        • Contact:
          • Nicole Seminara, MD
        • Contact:
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Not yet recruiting
        • Advanced Dermatology & Cosmetic Surgery
        • Contact:
          • Amylynne Frankel, MD
        • Contact:
    • Tennessee
      • Thompson's Station, Tennessee, United States, 37179
        • Recruiting
        • Delricht Research
        • Contact:
          • Pezhman Shoureshi, MD
        • Contact:
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research
        • Contact:
          • Edward Lain, MD
        • Contact:
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Acclaim Dermatology LLC
        • Contact:
          • Syed Ali, MD
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  1. Subject who is male ≥18 years old.
  2. Subject who has provided written informed consent.
  3. 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.
  4. Subject who is willing to maintain the same hairstyle, hair length and hair color throughout the study.
  5. Subject who is willing to comply with study instructions at home and return to the clinic for required visits.
  6. Subject who agrees to continue his shampoo frequency and other general hair care products and regimen for the entire study.
  7. Subject who agrees to maintain same dietary and supplement pattern.
  8. 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).

Exclusion Criteria:

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

  1. 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.
  2. 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.
  3. Subject who has current or recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding.
  4. Subject who had scalp hair transplants at any time.
  5. Subject with a history of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
  6. 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.).
  7. 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.
  8. Subject is currently enrolled in an investigational drug or device study.
  9. 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.
  10. Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  11. Subject who has used or is suspected, in the investigator's opinion, to be using anabolic steroids.
  12. 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.
  13. Subject who has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink.

  14. Subject who has used any of the following topical preparations or procedures on the scalp:

    1. 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.
    2. 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.
    3. 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.
    4. Scalp procedures (surgical, laser, light, or energy treatments, micro-needling, etc.) within 6 months of Visit 2/Baseline.
    5. Platelet rich plasma (PRP) procedure on the scalp within 6 months of Visit 2/Baseline.

  15. Subject who has used one or more of the following systemic medications or procedures:

    1. 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].
    2. Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline.
    3. Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.], Dutasteride or similar products within 6 months of Visit 2/Baseline.
    4. Chemotherapy or cytotoxic agents at any time.
    5. Radiation of the scalp at any time point.
    6. 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.
  16. Subject who has been previously enrolled in any study with Clascoterone (former CB 03 01).
  17. Subject who is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor.
  18. Subject who is institutionalized because of legal or regulatory order.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vehicle Part 1 + Clascoterone Part 2
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
Topical application of 1.5 ml of clascoterone solution 5%, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • CB-03-01 5% solution
Drug: Vehicle solution
Topical application of 1.5 ml of vehicle, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • Vehicle
Experimental: Clascoterone Part 1 and Part 2
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
Topical application of 1.5 ml of clascoterone solution 5%, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • CB-03-01 5% solution
Other: Clascoterone Part 1 + Vehicle Part 2
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
Topical application of 1.5 ml of clascoterone solution 5%, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • CB-03-01 5% solution
Drug: Vehicle solution
Topical application of 1.5 ml of vehicle, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • Vehicle
Placebo Comparator: Vehicle Part 1 and Part 2
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
Topical application of 1.5 ml of vehicle, twice a day, to balding areas of the scalp (vertex and temples)
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in non-vellus Total Area Hair Count (TAHC)
Time Frame: 6 months
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
Time Frame: 6 months
Subject's assessment of own hair coverage (i.e., subject's answer to item 2 of the Male Androgenetic Alopecia-Patient Reported Outcomes Questionnaire (MAA-PRO): "Right now, how is the coverage of your hair (the amount of your scalp with hair)?") at Month 6, defined as the proportion of MAA-PRO core measure item 2 responder at Month 6 threshold.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in non-vellus TAHC
Time Frame: 3 months
Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 3.
3 months
Changes in subject's assessment of satisfaction score
Time Frame: 6 months
Changes in MAA-PRO SI (Male Androgenetic Alopecia-Patient Reported Outcomes Satisfaction Index) single treatment satisfaction item (item 15) score (i.e. question: "How satisfied are you with the study treatment?") at Month 6, with a minimum value of "Very dissatisfied" and a maximum value of "Very satisfied."
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cassiopea SpA

Collaborators

ICON Clinical Research
Canfield Scientific Inc.
Ergomed PLC
Pharmapace Inc

Investigators

  • Study Director: Alessandro Mazzetti, M.D., Cassiopea SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-03-01/38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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