Sun Pharma Winlevi cream 1% reduces Sebum levels, suitable for combination with other commonly used topical acne medications: Study
Mumbai: Sun Pharmaceutical Industries Limited has presented data strengthening the clinical rationale for the use of WINLEVI (clascoterone) cream 1% to treat acne.
In poster presentations at the 44th Annual Fall Clinical Dermatology
Conference, data show WINLEVI significantly reduces sebum (oil) production and demonstrates excellent stability
in the presence of other commonly prescribed topical acne treatments, supporting the use of WINLEVI in
combination with those medications. Data also showed patients with skin of color, an under-represented population
in studies of acne medications, experienced reduced acne severity and tolerability while taking WINLEVI.
Collectively, the data continue to show that WINLEVI improves acne severity and is well tolerated.
WINLEVI is a androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne)
in patients 12 years of age and older, and the first and only FDA-approved topical treatment available in the U.S. that
targets sebum production in the skin.
Sebum is an oily wax that protects and moisturizes skin, but too much of it
feeds bacteria inside the skin, causing inflammation and acne lesions. Acne is the most prevalent skin condition in
the U.S., affecting up to 50 million Americans and 80% of people at some point during their lives. It is the most
common dermatological disorder in Black/African American and Hispanic/Latino populations. WINLEVI cream is a topical prescription medicine to treat acne in people 12 and older.
Researchers presented 12-week interim results from a yearlong study of the effect of WINLEVI on facial sebum
production in patients with acne. The study’s primary objective and efficacy endpoint was reduction in casual facial
sebum levels, as measured by a sebumeter, a device that directly measures the amount of lipids on the skin’s surface.
The study was also designed to assess the ability of WINLEVI to reduce the Investigator’s Global Assessment (IGA)
score, a scale designed for investigators to assess the level of facial acne (0 = clear, 1 = almost clear, 2 = mild, 3 =
moderate, 4 = severe). Other study objectives and efficacy endpoints included inflammatory and noninflammatory acne lesion counts, and investigator-assessed oily appearance, pore size, and facial shine; the latter three endpoints
were assessed on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe).
Among the 40 participating patients, the mean age was 20.9 years; most patients were female (60%) and White
(63%). All patients entered the study with mild (57.5%) or moderate (42.5%) acne, as well as a mean sebumeter
reading of 115.9 ± 50.5.
The researchers reported significant reductions in sebumeter measurements following use of WINLEVI at six (-22%,
P = 0.002), 10 (-19%, P = 0.005), and 12 weeks (-27%, P <0.001). They also observed significant improvements in
facial oily appearance after four weeks of WINLEVI treatment (-8%, P = 0.008), with continued improvement
through 12 weeks (-40%, P <0.001). Similarly, patients’ pore size improved significantly after six weeks (-13%, P =
0.002), and continued to improve through 12 weeks (-23%, P <0.001). Additionally, facial shine levels significantly
improved after four weeks (-9%, P = 0.004) with continued improvement through 12 weeks (-39%, P <0.001).
By Week 12, patients using WINLEVI experienced a statistically significant 29% reduction in IGA score (P <0.001).
Use of WINLEVI also resulted in significant reductions in the numbers of inflammatory and noninflammatory lesions
(-48% and -40%, respectively; P <0.001 for both measurements) after four weeks, with continued improvement
through 12 weeks (-54% and -34%, respectively; P <0.001 for both). WINLEVI was well tolerated through Week 12,
with no reports of adverse reactions.
“This is exciting news for people living with acne because this is the first study to demonstrate a reduction in
measured facial sebum production following the use of clascoterone cream 1%,” said lead investigator Zoe D.
Draelos, MD, of Dermatology Consulting Services, PLLC, in High Point, N.C. “In addition to confirming the sebumreducing effect of WINLEVI, our findings support data from previous clinical trials which showed reductions in the
number of inflammatory and noninflammatory lesions, further demonstrating the clinical utility of this topical acne
medication.”
Stability in combination therapy data
Dr. Draelos and colleagues also reported results from a study assessing the stability of WINLEVI when layered with
other topical acne medications such as tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid
15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and benzoyl peroxide
encapsulated 5%. Each of these medications were placed separately on individual microscope slides with WINLEVI
and incubated for eight hours at 37° Celsius. Material from the slides was extracted for analysis via high-performance
liquid chromatography-mass spectrometry (HPLC-MS).
recovered after layering ranged from 98% to 119%, indicating that none of the acne medications evaluated induced
degradation of WINLEVI when used in combination.
mechanisms of disease, has become standard practice in the treatment of acne,” commented Dr. Draelos. “In this in
vitro study, WINLEVI demonstrated consistent and reproducible stability in the presence of other acne medications.
Our findings support the combination of WINLEVI with topical retinoids, topical antibiotics, and/or benzoyl peroxide
as a viable acne treatment strategy and complement the encouraging results observed in the sebum reduction and skin
of color trials.”
study evaluating the efficacy and safety of WINLEVI in 10 patients (mean age 24 years) with skin of color
(Fitzpatrick skin types IV, V, and VI) and moderate-to-severe facial acne. The study met its primary endpoint, with
seven (78%) patients achieving an IGA score of 0 (clear) or 1 (almost clear) at Week 16 (P = 0.008 vs. baseline). The
study also met its secondary endpoints at Week 16, including significant reductions in inflammatory (91.8%, P =
0.008), noninflammatory (90.9%, P = 0.009), and total lesions (90.9%, P = 0.009). Investigator- and participantassessed tolerability parameters were absent or minimal at most time points through Week 16. There were no reports
of adverse events during the 16-week interim analysis period
