Clascoterone Cream 1%
Clascoterone Cream 1%
Product Description
Product overview
The world's first and only FDA-approved prescription topical antiandrogen for acne. Clascoterone 1% acts directly at androgen receptors in the skin — blocking DHT-driven sebum overproduction and inflammatory pathways at the source, without the systemic hormonal effects of oral spironolactone. A true breakthrough for hormonal acne in patients 12 years and older.
First-in-Class Mechanism
Clascoterone is the only topical androgen receptor inhibitor approved for acne. It competes with DHT at the androgen receptor in the sebaceous gland, reducing sebum overproduction at the molecular level.
Texture & feel
SENSORYFirst-in-Class Mechanism
Clascoterone is the only topical androgen receptor inhibitor approved for acne. It competes with DHT at the androgen receptor in the sebaceous gland, reducing sebum overproduction at the molecular level.
Targets Hormonal Acne Root Cause
Unlike retinoids or antibiotics, Winlevi directly addresses the androgen-driven pathway — the root cause of hormonal acne in both males and females, including jawline, chin, and cheek breakouts.
Locally Active, Systemically Safe
Clascoterone is rapidly metabolized in the skin to an inactive cortexolone form, minimizing systemic absorption. Unlike oral spironolactone, it does not cause blood pressure changes or gynecomastia in males.
Approved for Male & Female Patients
Unlike oral antiandrogens (e.g., spironolactone) which cannot be used in males due to feminizing effects, Winlevi is approved for both male and female patients 12 years of age and older.
Non-Drying Formula
Unlike retinoids or benzoyl peroxide, Winlevi's cream base with cetyl alcohol and vitamin E is moisturizing by design — reducing acne without stripping the skin barrier.
Combats Antibiotic Resistance
As a non-antibiotic treatment, Winlevi poses no risk of contributing to antibiotic resistance — an increasingly important consideration in long-term acne management.
Safety & compatibility
SAFENot established in humans. Animal studies at doses 8–39× the human dose showed fetal malformations. Use only if the potential benefit justifies the potential risk. Consult your healthcare provider.
It is unknown whether clascoterone passes into breast milk. Consult your doctor before using while breastfeeding. The prescribing label advises discussing feeding options with your healthcare provider.
NOT safe for fungal acne. The formula contains Polysorbate 80 (a polysorbate ester) and Mono & Diglycerides — both fatty acid esters known to feed Malassezia furfur. Avoid if you suspect pityrosporum folliculitis.
Unlike oral antiandrogens, Winlevi is the only topical antiandrogen approved for use in both males and females without risk of systemic feminizing side effects such as gynecomastia.
Hypothalamic-pituitary-adrenal (HPA) axis suppression can occur, especially with extensive use or in adolescents. All Phase 2 subjects normalized within 4 weeks of stopping treatment. Monitor with prolonged use.
Elevated potassium was observed in a small subset of patients in clinical trials. The risk is most significant in children under 12, which is one reason the product is not approved for that age group.
Winlevi contains no retinoids, benzoyl peroxide, salicylic acid, or antibiotics. This makes it complementary to many existing acne treatments and suitable as part of a multi-modal regimen.
Do not apply to eczematous, cut, abraded, or sunburned skin. Avoid contact with eyes, mouth, and mucous membranes. Wash hands before and after application.
Ingredient breakdown
INGREDIENTSClascoterone (Cortexolone 17α-Propionate) 1%Proven
The world's first topical androgen receptor inhibitor approved for acne. Clascoterone is a steroid derivative structurally similar to spironolactone and dihydrotestosterone (DHT). It competitively blocks the androgen receptor in sebaceous glands and hair follicles, reducing DHT-stimulated sebum production and downstream inflammatory cytokine synthesis — without entering systemic circulation in meaningful quantities.
- FDA Approval: Approved August 2020 (NDA 213433) for acne vulgaris, ages 12+
- Phase 3 Trials: Two pivotal RCTs (N=1,440) demonstrated statistically significant reductions in both inflammatory and non-inflammatory lesion counts vs. vehicle at 12 weeks
- IGA Success Rate: 18.4%–20.3% treatment success vs. 6.5%–9.0% vehicle (p<0.001)
- Lesion Reduction: Mean reduction of ~19 inflammatory lesions from baseline at week 12
- Mechanism: Competes with DHT for androgen receptor binding; rapidly metabolized locally to inactive cortexolone — limiting systemic effects
- Comparable to Tretinoin: A Phase 2 active-controlled trial found clascoterone similar in efficacy to topical tretinoin for mild-to-moderate acne
Cetyl Alcohol ~2.5%Emollient
A fatty alcohol (not a drying alcohol) that functions as an emollient and emulsion stabilizer. Cetyl alcohol gives the cream its soft, spreadable consistency and helps the active ingredient distribute evenly across the skin surface. Despite the "alcohol" in its name, it is non-irritating and non-drying — completely different from ethanol or denatured alcohol.
- Comedogenicity: Rated 2/5 — low to moderate; generally well tolerated
- Function: Emollient, thickener, emulsion stabilizer — improves skin feel
- Fatty Acid Note: Contains C16 fatty acid chain; may technically feed Malassezia — relevant for fungal acne sufferers
Tocopherol (Vitamin E) traceAntioxidant
A potent lipid-soluble antioxidant that protects the formula's oils from oxidative degradation. Tocopherol also provides mild skin-conditioning benefits, helping to maintain the skin barrier and neutralize free radicals at the skin surface. It contributes to the overall tolerability of the cream.
- Source: Naturally derived (d-alpha-tocopherol) or synthetic form
- Benefit: Stabilizes mineral oil component; mild anti-inflammatory skin conditioning
- Safety: Well tolerated; rare contact allergy possible in sensitive individuals
Propylene Glycol ~25%Humectant
A humectant and solvent that draws moisture into the skin and helps dissolve the active ingredient for even distribution. Propylene glycol also acts as a penetration enhancer, improving the delivery of clascoterone into the sebaceous follicle. Present in a relatively high proportion (250 mg per gram).
- Function: Humectant, solvent, penetration enhancer, preservation booster
- Concentration: 250 mg/g (per SmPC listing) — a notably active level
- Note: May cause mild stinging in some users with compromised barrier; patch test advised for sensitive skin
Mineral Oil (Paraffinum Liquidum) variableOcclusive
A well-refined occlusive emollient that forms a light barrier on the skin surface to reduce transepidermal water loss. Despite its reputation among natural beauty advocates, cosmetic-grade mineral oil is inert, non-sensitizing, and has a very low comedogenic rating. It contributes to the moisturizing, non-drying profile of the formula.
- Comedogenicity: 0–1/5 — cosmetic-grade mineral oil is generally non-comedogenic
- Safety: Extensively studied; no evidence of systemic toxicity from topical application
- Function: Softens skin, reduces water loss, improves spreadability
Polysorbate 80 + Mono & Diglycerides lowEmulsifier
Two emulsifying agents that keep the oil and water phases of the cream uniformly blended. Polysorbate 80 is a polyoxyethylene sorbitan ester with moderate emulsifying power. Mono and Diglycerides are partial glycerides that stabilize the formula. Both are effective and widely used — but both are esters that can serve as a food source for Malassezia yeasts, making this product unsuitable for fungal acne-prone individuals.
- Fungal Acne Flag: Polysorbate 80 and glyceride esters are known Malassezia-feeding ingredients
- Comedogenicity: Polysorbate 80 rated 1–2/5; generally considered low risk for comedones
- Function: Essential for cream stability and active ingredient distribution
11 ingredients
Active: Clascoterone 10 mg/g (1%)
Inactive: Cetyl Alcohol, Citric Acid Monohydrate, Edetate Disodium, Mineral Oil (Paraffinum Liquidum), Mono and Diglycerides, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol (Vitamin E)
Where it fits in your routine
ROUTINEApply after cleansing to clean, dry skin — both morning and evening. Allow 1–2 minutes to absorb before layering moisturizer. Do not spot-treat; apply a thin layer (~1g / 2 fingertip units) to the entire affected area for best results.
How to use
HOW TO USECleanse & Dry Thoroughly
Wash your face with a gentle, non-medicated cleanser and pat dry completely. Winlevi should be applied to clean, dry skin only — avoid applying to damp or wet skin, which can cause unnecessary irritation.
Dispense the Right Amount
Use approximately 1 gram — roughly equivalent to two fingertip units — per application. Do not over-apply; using excessive amounts does not improve efficacy and may increase the risk of local skin reactions.
Apply to the Full Affected Area
Spread a thin, uniform layer across the entire acne-prone area (full face or affected zones). Do not spot-treat individual pimples — whole-area application is essential for optimal results per the clinical protocol.
Wait, Then Layer
Allow 1–2 minutes for the cream to absorb before applying moisturizer or sunscreen. Avoid using harsh, abrasive, or alcohol-heavy toners or astringents immediately after application as these can intensify irritation.
Use Twice Daily — Consistently
Apply every morning and every evening. Consistency is critical: clinical trials were conducted at twice-daily application for 12 continuous weeks. If you miss a dose, apply at the next scheduled time — never double up.
Wash Hands Before & After
Always wash your hands before applying to avoid transferring bacteria, and again afterward to prevent accidental contact with eyes, mouth, or mucous membranes. If accidental contact occurs, rinse thoroughly with water.
Who is it for?
WHOPerfect for you if:
- You have moderate-to-severe hormonal or inflammatory acne (IGA 3–4)
- Your breakouts are concentrated along the jawline, chin, or cheeks
- You are male and cannot use oral antiandrogens like spironolactone
- You want a non-antibiotic, non-retinoid acne treatment option
- You've tried antibiotics or retinoids with incomplete results
- You are 12 years of age or older with a valid prescription
- You want to avoid systemic hormonal side effects
Consider alternatives if:
- You have fungal acne (pityrosporum folliculitis) — formula is NOT safe
- You are pregnant or trying to conceive — safety not established
- You are under 12 years old — not approved for this age group
- You have eczema, active cuts, abrasions, or sunburned skin
- You have mild, non-hormonal acne — other options may be sufficient
- Cost is a primary concern — Winlevi can cost ~$580 for a 60g tube without insurance
- You cannot commit to twice-daily application for at least 12 weeks
Skin type compatibility
SKIN TYPESThe primary target population. Winlevi directly reduces androgen-driven sebum overproduction — the core driver of oily, acne-prone skin. Most effective for seborrheic, cystic, or comedonal acne rooted in hormonal activity.
Works particularly well on the oily T-zone and hormonal breakout zones (chin, jawline). The moisturizing cream base prevents over-drying of drier areas of the face during treatment.
The emollient cream base with mineral oil and cetyl alcohol is gentler on dry skin than retinoids or benzoyl peroxide. A good moisturizer layered on top completes the routine comfortably.
Fragrance-free and paraben-free, but propylene glycol (at ~25%) can cause stinging or tingling on reactive or barrier-compromised skin. Patch test first; watch for redness, scaling, or itching.
Well tolerated on normal skin types. The moisturizing base maintains skin balance; mild side effects (trace erythema, mild scaling) were similar to vehicle cream in clinical trials.
Results timeline
3–6 MONTHSInitial Adjustment Phase
Some users report mild redness, scaling, or tingling as skin adjusts to the formula. Unlike retinoids, there is no traditional "purging" phase with clascoterone. Skin begins acclimating to twice-daily application. Keep your routine simple and moisturize well.
Early tolerance buildingFirst Noticeable Improvements
Many patients begin to see fewer new breakouts forming and a reduction in inflammatory lesion severity. Sebum production may noticeably decrease. The brand website notes users can start seeing improvements around week 4.
~40% notice initial changesMeasurable Lesion Reduction
The primary study endpoint was 12 weeks. Phase 3 data showed a mean reduction of ~19 inflammatory lesions and ~19 non-inflammatory lesions from baseline. Treatment success (IGA 0/1) achieved by 18–20% of patients in pivotal trials.
18–20% IGA success (vs 6–9% vehicle)Sustained Acne Control
With continued twice-daily use, Winlevi maintains androgen receptor blockade at the follicle level, helping prevent future breakouts. The 12-month open-label extension study confirmed the sustained safety profile with ongoing use.
Long-term maintenance benefitRatings by platform
92+ REVIEWSPros & cons
BALANCEDPraised
- Unique mechanism: only topical antiandrogen available
- Approved for both males and females (unlike oral spiro)
- Non-drying cream base — gentler than retinoids/BPO
- No antibiotic resistance concerns
- Fragrance-free, paraben-free formula
- Minimal systemic absorption — localized action
- Non-comedogenic (mineral oil + cetyl alcohol: 1–2/5)
- Clinically proven in two robust Phase 3 trials (N=1,440)
Criticized
- Very expensive (~$580/60g without insurance)
- Prescription-only — requires healthcare provider visit
- Rich, creamy texture can leave white residue or streaks
- Contains Polysorbate 80 — NOT fungal acne safe
- Results require 8–12 weeks of consistent twice-daily use
- HPA axis suppression possible with extended use
- IGA success rate ~18–20% — not a "cure-all"
- Pregnancy and breastfeeding safety not established
Budget-friendly alternatives
DUPESAvailable through compounding pharmacies with a prescription. Targets the same androgen pathway via mineralocorticoid receptor blockade. Less clinical evidence than Winlevi, not FDA-approved as a specific formulation, but widely used off-label by dermatologists — particularly for female patients.
The systemic antiandrogen often compared to Winlevi. Highly effective for hormonal acne in females, but causes systemic effects including menstrual irregularities, blood pressure changes, and potassium fluctuations. Not usable in males due to feminizing side effects. Winlevi was specifically developed to offer spironolactone-like efficacy without systemic risks.
A retinoid that works via a completely different mechanism — normalizing cell turnover and reducing follicular plugging. Available over the counter without a prescription. Does not target androgens or sebum production directly, but is highly effective for comedonal and mild-to-moderate acne. More drying than Winlevi; suitable as a companion product rather than a true alternative.
Comparison with competitors
SIDE-BY-SIDETretinoin 0.025–0.1% Cream (Generic Retinoid)
Oral Spironolactone 50–100mg (Generic)
Storage & shelf life
12 MONTHS12 months after opening. Check the expiry date printed on the tube — do not use after the stated expiration date even if the tube has not been opened.
Store at controlled room temperature — 68°F to 77°F (20°C to 25°C). Keep away from heat, direct sunlight, and humidity. Do not refrigerate or freeze. Keep out of reach of children.
Aluminum tube with screw cap, available in 30g (1 oz) and 60g (2 oz) sizes. The tube format minimizes contamination and oxidation compared to open jars. Apply by squeezing a small amount onto clean fingertips.
The 30g tube qualifies as under 100ml and is compliant with TSA/carry-on liquid restrictions. Place in a clear plastic bag with other liquids and gels for airport security screening.
Frequently asked questions
FAQSafety has not been established in pregnant or breastfeeding humans. Animal studies conducted with subcutaneous administration at doses 8 to 39 times the human dose demonstrated organ malformations in rat fetuses. It is also unknown whether clascoterone passes into breast milk. The prescribing label states: "It is not known if WINLEVI cream will harm your unborn baby." If you are pregnant, planning to become pregnant, or breastfeeding, you should discuss with your healthcare provider before using this product. In general, Winlevi should be classified as Caution for pregnancy — avoid unless specifically directed by a physician who has weighed the risk-benefit profile.
No — Winlevi is NOT safe for fungal acne. The formulation contains two ingredients that are known to feed Malassezia yeast: Polysorbate 80 (a polyoxyethylene sorbitan ester) and Mono and Diglycerides (fatty acid glycerol esters). Both of these can serve as a nutrient source for Malassezia furfur, the organism responsible for pityrosporum folliculitis. If you suspect you have fungal acne — characterized by small, uniform, itchy papules and pustules often on the forehead, temples, or chest — consult your dermatologist before starting Winlevi. An antifungal treatment and a Malassezia-safe acne protocol would be more appropriate.
Winlevi can be combined with other topical actives, but caution and timing are important. The prescribing information advises limiting the use of other potentially irritating topical products alongside Winlevi — specifically: medicated or abrasive soaps, cleansers with strong drying effects, high-concentration alcohol products, astringents, and products containing spices or lime. Retinoids (tretinoin, adapalene) can be used in the same regimen but ideally at different application times (e.g., Winlevi in the AM, retinoid in the PM) to minimize cumulative irritation. Similarly, AHAs, BHAs, or vitamin C serums should be used at a different time of day if concurrent irritation occurs. There are no known pharmacokinetic drug interactions; no significant effects on CYP enzymes were found in vitro. Always introduce one new active at a time and monitor for skin barrier disruption.
Winlevi is best suited for oily and combination skin types with moderate-to-severe hormonal acne (IGA score 3–4). It is particularly effective for patients experiencing androgen-driven breakouts — characterized by deep, inflamed pimples concentrated along the jawline, chin, and lower cheeks, often worsening with hormonal fluctuations (menstrual cycle, puberty, stress). The cream base makes it more tolerable than retinoids for dry skin types, but the propylene glycol content (~25%) can cause minor stinging on sensitive or barrier-compromised skin. It is not ideal for fungal acne, regardless of skin type. Best results are seen in patients with moderate-to-severe inflammatory or mixed (inflammatory + comedonal) facial acne with a hormonal component.
Initial improvements may be noticed around 4 weeks of consistent twice-daily use. However, the pivotal Phase 3 clinical trials assessed outcomes at 12 weeks — and this is the timeframe used to evaluate meaningful clinical efficacy. Statistically significant reductions in both inflammatory lesion counts (~19 lesions from baseline) and non-inflammatory lesions were demonstrated at week 12. Treatment success (IGA 0 or 1, i.e., clear or almost clear) was achieved in 18–20% of patients versus 6–9% in the vehicle group. It is important to maintain a consistent twice-daily routine for a full 12 weeks before evaluating whether the treatment is working for you. Do not discontinue prematurely — like most prescription acne treatments, early patience is required.
Winlevi is applied after cleansing and before moisturizer, twice daily — morning and evening. The correct routine order is: (1) Gentle Cleanser → (2) Optional Toner → (3) Winlevi Cream (applied to clean, dry skin, ~1g / 2 fingertip units) → (4) Moisturizer → (5) Sunscreen (AM only). Wait 1–2 minutes after applying Winlevi before layering moisturizer. Avoid using harsh, drying, or alcohol-heavy products immediately after application. Unlike retinoids, Winlevi can be used in the morning without photosensitivity concerns, making the twice-daily protocol more flexible.
Winlevi has a comedogenic rating of approximately 2/5 — considered low. The key potentially comedogenic ingredients are cetyl alcohol (rated 2/5) and mineral oil (rated 0–1/5 for cosmetic-grade formulations). In practice, because Winlevi directly reduces androgen-driven sebum production, it generally helps to reduce the conditions that lead to comedones rather than worsen them. Some user reviews do mention clogged pores or new comedones during early use — this may reflect the initial adjustment period or the cream base interacting with individual skin chemistry. For users with highly comedone-prone skin, discuss with your dermatologist and monitor response during the first 4 weeks. The formula does not contain any heavy waxes, butters, or high-rated comedogenic oils.
Winlevi Cream should be used within 12 months of opening. At twice-daily whole-face application (~1g per application), a 30g tube lasts approximately 2 weeks and a 60g tube approximately 4 weeks with consistent use. Store at room temperature (68–77°F / 20–25°C), away from heat and direct sunlight. Always check the expiry date on the tube. Do not use after the printed expiration date regardless of whether the tube has been opened. Keep the cap tightly closed after each use to prevent contamination and oxidative degradation of the formula.
Verdict: Winlevi (Clascoterone 1%) is a genuinely groundbreaking prescription acne treatment — the first and only FDA-approved topical androgen receptor inhibitor for acne vulgaris. For patients with moderate-to-severe hormonal acne who have not achieved adequate control with retinoids, antibiotics, or oral contraceptives, Winlevi offers a novel and locally-targeted mechanism with minimal systemic risk. It is particularly valuable for male patients, who cannot use oral antiandrogens like spironolactone. The cream base is gentler than most acne treatments, and the twice-daily protocol is straightforward. The key limitations are the high cost (~$580 without insurance), the prescription-only requirement, and the fact that results require 12 weeks of consistent use — with modest IGA success rates of 18–20% in clinical trials. It works best as part of a multi-modal regimen rather than as monotherapy.Not recommended for fungal acne or pregnancy. For hormonal acne in appropriate candidates, Winlevi is a meaningful clinical advance worth discussing with a dermatologist.
Product Overview
Quick product notes are a great way to check if a product is free from commonly avoided ingredients by skincare enthusiasts. These preferences come about for different reasons depending on the ingredient such as personal experiences, sensitivities, health preferences & etc.
Just because a product is not free from a common preference does not mean it's a bad product! You can make a personal decision whether or not you want to use a product that contains these ingredients or not - click the labels of the preference to read more about them.
Quick Product Notes
Ever used a product that promised a certain effect but provided no results? It might not have contained any notable ingredients that could have been responsible for that promised effect. It doesn't matter what the marketing or packaging «promises» it can do, if it doesn't contain anything that can help - then the likelihood of it helping is low.
We help you identify key notable ingredients that have been shown to help with effects such as acne-fighting, brightening, UV-protection, wound healing & anti-aging to help you achieve your skincare goals smarter. Please note that different notable ingredients have varying levels of research behind them, some are extremely well proven yet some have mixed research in their efficacy.
Just because a product doesn't contain any notable ingredients doesn't mean it's bad. And a product with notable ingredients (or even many) doesn't necessarily guarantee the efficacy of the product performing these effects either. There are other factors such as ingredient quality, concentration and formulation that will ultimately determine this.
Be smart and use this as just a starting point for you to make more informed and smarter choices and compare it with reviews to see if the product is right for you
Notable Effects & Ingredients
Why are some products great for some people and horrible for others? Well everyone has different skin types and different reactions to the same ingredients.
We've identified a range of ingredients that are commonly regarded as potentially good or bad for those with Dry, Oily/Acne-Prone or Sensitive skin.
A product that contains good or bad ingredients for your skin type doesn't always flat out make the entire product good or bad for your skin. There are other factors such as ingredient quality, concentration and formulation that will ultimately determine your skins reaction.
One of the best ways to use this section is to troubleshoot products you've had bad experiences with in the past. Check if it contains any of the marked ingredients to point out suspect ingredients to avoid in the future!
Ingredients Related to Skin Types
Ingredient Safety Breakdown refers to the percentage % of ingredients in different risk categories as classified by EWG (Environment Working Group) if they are available. There are almost endless cosmetic ingredients and they are one of the few organisations globally that have assigned ratings to a lot of the more commonly used ingredients which is why we reference them.
EWG is seen by many to be more on the alarmist side in their assignment of health ratings resulting in rating ingredients as riskier than they actually are. We recommend using this a reference point rather than a strict guide of ingredient safety and to always do further research if into ingredients that you may find suspect.
Ingredient Safety Breakdown
Product ingredient list
| EWG | CIR | Ingredient Name & Cosmetic Functions | Notes |
|---|---|---|---|
| 0 |
Clascoterone
|
|
|
| 1 |
Cetyl Alcohol
Emulsion Stabilising, Fragrance, Opacifying, Emulsifying, Surfactant, Foam Boosting, Viscosity Increasing Agent, Emollient, Masking, Viscosity Controlling
|
|
|
| 2 |
Citric Acid
Masking, Fragrance, Chelating Agent, Ph Adjuster, Buffering Agent
|
Promotes Wound Healing
Texture
Pores
|
|
| 1 |
Disodium EDTA
Viscosity Controlling, Chelating Agent
|
|
|
| 0 |
Paraffinum Liquidum
Emollient, Skin Protecting, Solvent
|
|




