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Evaluation of topical clascoterone versus drug combination for skin vasoconstriction in healthy volunteers

Registered drug
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial examines how two topical anti‑androgen formulations, a clascoterone cream (1%) and a clascoterone solution (5%), affect the narrowing of small blood vessels in the skin, a process known as vasoconstriction. The study compares these test products with three commonly used steroid creams: one containing clobetasol propionate, another with hydrocortisone, and a third with betamethasone valerate. All applications are made to areas of healthy skin, and the degree of vessel narrowing is observed as a temporary lightening of the skin, called skin blanching.

The purpose of the study is to determine how strongly the two test formulations cause vasoconstriction compared with the three steroid creams and with their corresponding inactive bases (placebos). Participants receive a single dose of each product on separate skin sites, and the skin color change is measured at several intervals up to 24 hours after the product is removed.

The study is a phase 1, randomized, open‑label trial conducted at one center. After each application, trained staff record the skin’s appearance using a simple color‑matching method, allowing the researchers to compare the intensity and duration of the skin blanching effect across all products and placebos.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Skin Measurement

    Baseline skin measurement is performed on the designated test area before any product is applied. The measurement records the natural color of the skin using a standardized instrument.

  2. Step 2

    Application of Test Products

    A single dose of each study product is applied to a separate small area of healthy skin. The products and their amounts are:

    Clascoterone cream 1% – 2 mg applied once.

    Clascoterone solution 5% – 10 mg applied once.

    HydroGalen® cream (hydrocortisone) – 2 mg applied once.

    BetaGalen® cream (betamethasone valerate) – 0.2 mg applied once.

    ClobeGalen® cream (clobetasol propionate) – 0.1 mg applied once.

    Placebo vehicle cream – applied once (no active ingredient).

    Placebo vehicle solution – applied once (no active ingredient).

  3. Step 3

    Removal of Product

    After the prescribed exposure time, each product is gently removed from the skin. The exact exposure time follows the study protocol and is the same for all products.

  4. Step 4

    Follow‑Up Skin Measurements

    Skin color is measured again at four timepoints after the product has been removed:

    1 hour after removal.

    3 hours after removal.

    6 hours after removal.

    24 hours after removal.

    These measurements allow comparison of the vasoconstriction (skin blanching) effect of each product.

  5. Step 5

    Study Completion

    After the 24‑hour measurement, no further study procedures are required. The participant’s involvement in the trial is finished.

Who can join the trial?

5 criteria

  • Written informed consent must be signed, meaning you agree to join the study after it has been explained to you.
  • You must be a man or woman aged 18 to 50 years with healthy skin in the area where the test will be applied.
  • You need to show a normal skin‑blanching reaction (called vasoconstriction) after a 24‑hour covered (occlusive) use of BetaGelen® Creme 0.1% (a steroid cream), which means you are a “responder.”
  • If you are a woman who could become pregnant (childbearing potential), you must either be permanently unable to become pregnant (permanently sterile) or agree to use a reliable birth‑control method that fails less than 1 % of the time each year, during the study and for at least one week after the last dose.
  • You must have a negative urine pregnancy test at the screening visit and on the first day of the study.

Who cannot join the trial?

24 criteria

  • You are pregnant or planning to become pregnant.
  • You have a known or suspected allergy to any ingredient in the study medicines.
  • You are allergic to the adhesive (sticky part) on medical tape.
  • Your doctor has listed any contraindications (situations where a medicine should not be used) for these products.
  • You have applied steroid creams or ointments (topical corticosteroids) to your forearms in the past 4 weeks.
  • You have taken oral or skin medicines that could affect the skin‑color test (such as steroids, blood‑pressure medicines, allergy medicines, pain relievers like ibuprofen or aspirin) within the past 2 weeks.
  • You have used any skin medicines on your forearms in the past week.
  • You have applied moisturizers, skin creams, or similar products to your forearms in the 24 hours before the study starts.
  • You consume more than about three cups of coffee (or other caffeinated drinks) per day from the day before screening until the end of the study.
  • You currently smoke cigarettes or other tobacco.
  • You have been part of another clinical trial that was still giving treatment within the past 4 weeks.
  • You are a woman who is breastfeeding a baby.
  • You have taken any experimental drug that is not yet approved for normal use within the past 4 weeks.
  • You are unwilling to refrain from heavy exercise or drinking alcohol while the study is running.
  • The doctor believes you may not be able to follow the study rules or understand the consent.
  • You are a close family member, employee, or staff member of the study team or sponsor.
  • You are living in a facility because of a legal or court order.
  • Your two arms have a clearly different skin colour.
  • You have any active skin infection (such as cold sores, chickenpox, fungal or bacterial infections), fragile skin, stretch marks, conditions like ichthyosis, ulcers, or any irritation, redness, dryness, scaling, scars, moles, or sunburn on the forearms.
  • You have any ongoing body‑wide or skin disease (such as eczema, allergic skin rash, or psoriasis) that could affect the test results.
  • You have a past or current problem with drug or alcohol abuse.
  • You would need to shave the front of your forearms for the study.
  • You have been in strong sunlight or used a tanning bed heavily in the week before the study starts, as judged by the doctor.
  • You have very dark skin (skin type V or VI on the Fitzpatrick scale) or unusual skin colouring that could affect the test.
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Investigated drugs

  • ClobeGalen® Creme

    is a cream that contains a strong steroid called clobetasol. In the study it is used as a reference product to compare how much it can cause the skin to narrow blood vessels (vasoconstriction) and make the skin look lighter. This helps researchers see how the test medicines perform against a known potent steroid.

  • HydroGalen® Creme

    is a cream that contains hydrocortisone, a mild steroid that is often used to calm skin irritation. In the trial it serves as another reference product, allowing the study team to compare the test medicines with a less powerful steroid and understand the range of effects.

  • BetaGalen® Creme

    is a cream that contains betamethasone valerate, a medium‑strength steroid. It is included in the trial as a third reference product so the researchers can see how the test medicines stack up against a steroid of intermediate potency.

  • Clascoterone Solution

    is a clear liquid that is applied to the skin and contains clascoterone, a medication that blocks the effects of male hormones on the skin. In this study it is being tested to see how well it can cause the skin’s blood vessels to tighten and produce a lightening (blanching) effect, which is a way to measure its strength.

  • Cortexolone 17alpha‑propionate 1% cream

    is a cream that also contains clascoterone (the same active ingredient as the solution). It is tested in the same way as the solution, but in a cream form, to find out how the different formulation influences its ability to cause skin blanching.

What is already known about the treatment

  • ClobeGalen® Creme

    This is a cream applied to the skin (topical application) that contains 0.1 mg of clobetasol propionate per gram. Clobetasol propionate is a prescription‑only, very potent corticosteroid that is well established in medical literature and used for a variety of inflammatory skin disorders. It works by binding to glucocorticoid receptors inside skin cells, which reduces inflammation and suppresses immune responses. Pharmacologically it is classified as a very high‑potency topical corticosteroid.

  • Clascoterone Solution

    This is a clear solution applied to the skin that delivers 10 mg of clascoterone per gram (5 % strength). Clascoterone is a newer topical anti‑androgen that has been approved for acne treatment and is being studied for other skin uses. It blocks androgen receptors in the skin, lowering the effect of male hormones that can cause oil production and inflammation. It is classified as a topical anti‑androgenic steroid.

  • cortexolone 17α‑proprionate 1% cream

    This cream is spread on the skin (topical application) and provides 2 mg of cortexolone 17α‑proprionate per gram (1 % strength). Cortexolone 17α‑proprionate, also known as clascoterone, is an investigational topical anti‑androgen currently in clinical studies for acne and other skin conditions. It works by attaching to androgen receptors in skin cells, preventing the hormones from triggering excess oil and inflammation. It belongs to the class of topical anti‑androgenic steroids.

  • HydroGalen® Creme

    This is a cream for topical use that contains 2 mg of hydrocortisone per gram. Hydrocortisone is an over‑the‑counter, mild corticosteroid that has been used for many years to treat mild inflammation, itching, and allergic skin reactions. It reduces inflammation by activating glucocorticoid receptors, which calm the immune response in the skin. It is classified as a low‑potency topical corticosteroid.

  • BetaGalen® Creme

    This cream is applied to the skin and delivers 0.2 mg of betamethasone valerate per gram. Betamethasone valerate is a prescription‑only, medium‑potency corticosteroid that is widely used for inflammatory skin disorders such as eczema and psoriasis. It works by binding to glucocorticoid receptors, leading to a strong anti‑inflammatory and immunosuppressive effect in the skin. Pharmacologically it is a medium‑potency topical corticosteroid.

Investigated diseases

Conditions this trial is registered against

Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507241-28-00Protocol codeCB-03-01/39Estimated enrolment33 patientsSponsorCassiopea S.p.A.

sourced from the EU Clinical Trials Register and site verification

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