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Alopecia, AndrogeneticPhase 3SCALP2NCT05914805

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

A Phase 3 study testing Clascoterone 5% solution in people with Alopecia, Androgenetic, run by Cassiopea SpA at 27 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Alopecia, Androgenetic
What is being tested?
Clascoterone 5% solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
762 participants
Where
27 sitesin 3 countries
Study dates
17 Aug 2023to 16 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.
Show all 30Show fewer
  • 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:
  • 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.
  • 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.
  • 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.
  • Scalp procedures (surgical, laser, light, or energy treatments, micro-needling, etc.) within 6 months of Visit 2/Baseline.
  • 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:
  • 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].
  • Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline.
  • Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.], Dutasteride or similar products within 6 months of Visit 2/Baseline.
  • Chemotherapy or cytotoxic agents at any time.
  • 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, 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.

Trial locations and contacts

27 sites in 3 countries.

27 sites in 3 countries

United States12 sites

  • DelRicht Research

    Atlanta, Georgia, 30329

  • Physician's Institute of Cosmetic and Reconstructive Surgery

    Hollywood, Florida, 33021

  • Piedmont Plastic Surgery and Dermatology

    Huntersville, North Carolina, 28078

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • Investigate MD

    Scottsdale, Arizona, 85255

  • Advanced Dermatology & Cosmetic Surgery

    Spartanburg, South Carolina, 29307

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Acclaim Dermatology LLC

    Sugar Land, Texas, 77479

  • DelRicht Research

    Thompson's Station, Tennessee, 37179

  • Revival Research Institute

    Troy, Michigan, 48084

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • DelRicht Research

    Wildwood, Missouri, 63040

Other trials in United States

Poland9 sites

  • Centrum Medyczne Pratia

    Katowice, 40-081

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Centrum Medyczne All-med Badania Kliniczne

    Krakow, 30-033

  • Centrum Nowoczesnych Terapii Dobry Lekarz

    Krakow, 31-011

  • Diamond Clinic Sp. z o.o.

    Krakow, 31-559

  • Dermoklinika Centrum Medyczne s.c. M. Kierstan, J.Narbutt, A. Lesiak

    Lodz, 90-436

  • Pro Life Medica

    Lublin, 20-412

  • Narodowy Instytut Geriatrii, Reumatologii iRehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warsaw, 02-637

  • Carpe Diem Centrum Medycyny Estetycznej

    Warsaw, 02-661

Other trials in Poland

Germany6 sites

  • Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergology, Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Emovis GmbH

    Berlin, 10629

  • Privatpraxis Dr. Hilton & Partner

    Düsseldorf, 40212

  • Dermaticum-Privatpraxis für Dermatologie

    Freiburg im Breisgau, 79098

  • Eurofins | bioskin

    Hamburg, 20095

  • Department of Dermatology and Allergy, Johannes Gutenberg-Universität KöR

    Mainz, 55131

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Being tested
Clascoterone 5% solution, Vehicle solution
Keywords
Alopecia, Androgenetic, Clascoterone solution, Phase 3, Randomized, Double-blind, Vehicle-controlled, AGA
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clascoterone 5% solutionDrug

    Also called CB-03-01 5% solution

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

  • Vehicle solutionDrug

    Also called Vehicle

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

Study groups in NCT05914805
Study groupRoleWhat they receive
Clascoterone Part 1 and Part 2ExperimentalSubjects treated for 12 months with Clascoterone 5% solution (both in double-blind Part 1 and in the single-blind Part 2 of the study).
Receives: Drug: Clascoterone 5% solution
Clascoterone Part 1 + Vehicle Part 2OtherSubjects 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.
Receives: Drug: Clascoterone 5% solution; Drug: Vehicle solution
Vehicle Part 1 + Clascoterone Part 2OtherSubjects 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.
Receives: Drug: Clascoterone 5% solution; Drug: Vehicle solution
Vehicle Part 1 and Part 2Placebo comparatorSubjects treated for 12 months with Vehicle (both in double-blind Part 1 and in the single-blind Part 2 of the study).
Receives: Drug: Vehicle solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (2)

  1. Changes in non-vellus TAHC

    Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 3.

    Measured: 3 months

  2. Changes in subject's assessment of satisfaction score

    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."

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start17 Aug 2023
  3. Primary completion16 Jul 2025
  4. Study completion16 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
762 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914805
Sponsor's protocol ID
CB-03-01/38
Acronym
SCALP2
Status last verified
Dec 2025
First submitted
6 Jun 2023
Last updated
22 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clascoterone 5% solution in people with Alopecia, Androgenetic, run by Cassiopea SpA at 27 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in non-vellus Total Area Hair Count (TAHC) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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