Papular-pustular RosaceaPhase 2NCT06952517

Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea

A Phase 2 study testing Clascoterone Cream 1% in people with Papular-pustular Rosacea and Papulopustular Rosacea (PPR), run by Narrows Institute for Biomedical Research at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Papular-pustular Rosacea, Papulopustular Rosacea (PPR), Papulopustular Rosacea
What is being tested?: Clascoterone Cream 1%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2025to 30 Sep 2025
Phase: Phase 2
Are there results?: Not yet: the study is under way

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women ages 18+.
Diagnosis of rosacea type 2 (papulopustular).
Available and willing to comply with study instructions and attend all study visits.
Able and willing to provide written and verbal informed consent.
Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Who cannot join

Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.

Show all 9Show fewer

Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kayla N Zafar, BA contact

718-836-6600 ext. 7023

kayla.zafar@va.gov

United States1 site, 1 recruiting

New York Harbor VA Brooklyn Campus
Brooklyn, New York, 11209
Kayla Zafar, BA, 718-836-6600 ext. 7023, kayla.zafar@va.gov
Jared Jagdeo, MD MS
Recruiting

Other trials in United States

About this study

Official title: Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea

To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

Conditions: Papular-pustular Rosacea, Papulopustular Rosacea (PPR), Papulopustular Rosacea
Being tested: Clascoterone Cream 1%
Keywords: rosacea, papulopustular rosacea, acneiform rosacea, PPR
Medical subject headings: Rosacea

What participants receive

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

Clascoterone Cream 1%Drug
Also called WINLEVI
Clascoterone 1% cream

Study groups in NCT06952517
Study group	Role	What they receive
Patients with Acneiform or Papulopustular Rosacea	Experimental	Patients with diagnosis of papulopustular or acneiform rosacea Receives: Drug: Clascoterone Cream 1%

What is being measured

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

Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
We will perform both a paired and pooled statistical analysis. We will conduct a power analysis to determine statistical significance. For the paired analysis, we will calculate the average gland size per patient at baseline and again at the end of the treatment period from all the individual's biopsy sites. We will then calculate the percent reduction of sebaceous gland size between the two average sizes. Finally, we will calculate the average percent change across all participants.
For the pooled analysis, we will calculate the average sebaceous gland size across all study participants before and after treatment. We will use these two values to calculate the percent change. We anticipate that the paired analysis will yield more meaningful results as the pooled analysis may not show significant change due to the variations between study participants used to calculate the averages.
Measured: From enrollment to end of treatment at 12 weeks

Secondary outcomes (3)

Evaluation of safety and adverse events
We plan to calculate the incidence of adverse events. Study participants will be instructed to keep a log of all adverse events.
Measured: From enrollment to end of treatment at 12 weeks
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Measured: From enrollment to end of treatment at 12 weeks
Physician and study participants reported assessments at the end of the treatment compared to baseline
A modified, succinct version of the Rosacea clinical scorecard as proposed by the Report of the National Rosacea Society Expert Committee on the Classification and Staging of sRosacea will be used to assess these measures. Physicians and study participants will be asked to grade the rosacea at baseline and at the end of the treatment based on the following scale:
- Subtype 1: Erythematotelangiectatic: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
- Subtype 2: Papulopustular: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
- Subtype 3: Phymatous: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
- Global Assessment: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
Measured: From enrollment to end of treatment at 12 weeks

Timeline

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

14 Mar 202530 Sep 2025

First posted1 May 2025
Study start14 Mar 2025
Primary completion1 Sep 2025 (estimated)
Study completion30 Sep 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Papular-pustular RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06952517
Sponsor's protocol ID: 1760535
Status last verified: Apr 2025
First submitted: 23 Apr 2025
Last updated: 6 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: IPD may not be shared because this study is conducted at a VA hospital with a small sample size

Publications

Liakou AI, Nyengaard JR, Bonovas S, Knolle J, Makrantonaki E, Zouboulis CC. Marked Reduction of the Number and Individual Volume of Sebaceous Glands in Psoriatic Lesions. Dermatology. 2016;232(4):415-24. doi: 10.1159/000445942. Epub 2016 Jun 2.
PubMed 27250651
Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available.
PubMed 15153893
Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Deret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7.
PubMed 25848978
Brelsford M, Beute TC. Preventing and managing the side effects of isotretinoin. Semin Cutan Med Surg. 2008 Sep;27(3):197-206. doi: 10.1016/j.sder.2008.07.002.
PubMed 18786498
Khalil NY, Darwish IA, Al-Qahtani AA. Isotretinoin. Profiles Drug Subst Excip Relat Methodol. 2020;45:119-157. doi: 10.1016/bs.podrm.2019.10.005. Epub 2019 Dec 6.
PubMed 32164966
Tan J, Schofer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia - The RISE study. J Eur Acad Dermatol Venereol. 2016 Mar;30(3):428-34. doi: 10.1111/jdv.13556.
PubMed 26915718

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea
ClinicalTrials.gov ID: NCT06952517
Acronym / sponsor ID: 1760535
Conditions: Papular-pustular Rosacea, Papulopustular Rosacea (PPR), Papulopustular Rosacea
Keywords: rosacea, papulopustular rosacea, acneiform rosacea, PPR
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Narrows Institute for Biomedical ResearchUniversity, hospital or other
Collaborators: Sun Pharmaceutical Industries Limited
Study start: 14 Mar 2025 (actual)
Primary completion: 1 Sep 2025 (estimated)
Study completion: 30 Sep 2025 (estimated)
First posted: 1 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with Acneiform or Papulopustular Rosacea	Experimental	Drug: Clascoterone Cream 1%Patients with diagnosis of papulopustular or acneiform rosacea

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men and women ages 18+.
Diagnosis of rosacea type 2 (papulopustular).
Available and willing to comply with study instructions and attend all study visits.
Able and willing to provide written and verbal informed consent.
Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Key exclusion criteria (9 listed)

Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clascoterone Cream 1%Also: WINLEVIClascoterone 1% cream	Drug	Patients with Acneiform or Papulopustular Rosacea

Primary outcome

Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
Time frame: From enrollment to end of treatment at 12 weeks
We will perform both a paired and pooled statistical analysis. We will conduct a power analysis to determine statistical significance. For the paired analysis, we will calculate the average gland size per patient at baseline and again at the end of the treatment period from all the individual's biopsy sites. We will then calculate the percent reduction of sebaceous gland size between the two average sizes. Finally, we will calculate the average percent change across all participants. For the pooled analysis, we will calculate the average sebaceous gland size across all study participants before and after treatment. We will use these two values to calculate the percent change. We anticipate that the paired analysis will yield more meaningful results as the pooled analysis may not show significant change due to the variations between study participants used to calculate the averages.

3 secondary outcomes

Evaluation of safety and adverse events
Time frame: From enrollment to end of treatment at 12 weeks
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Time frame: From enrollment to end of treatment at 12 weeks
Physician and study participants reported assessments at the end of the treatment compared to baseline
Time frame: From enrollment to end of treatment at 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Background: PubMed 27250651Liakou AI, Nyengaard JR, Bonovas S, Knolle J, Makrantonaki E, Zouboulis CC. Marked Reduction of the Number and Individual Volume of Sebaceous Glands in Psoriatic Lesions. Dermatology. 2016;232(4):415-24. doi: 10.1159/000445942. Epub 2016 Jun 2.
Background: PubMed 15153893Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available.
Background: PubMed 25848978Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Deret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7.
Background: PubMed 18786498Brelsford M, Beute TC. Preventing and managing the side effects of isotretinoin. Semin Cutan Med Surg. 2008 Sep;27(3):197-206. doi: 10.1016/j.sder.2008.07.002.
Background: PubMed 32164966Khalil NY, Darwish IA, Al-Qahtani AA. Isotretinoin. Profiles Drug Subst Excip Relat Methodol. 2020;45:119-157. doi: 10.1016/bs.podrm.2019.10.005. Epub 2019 Dec 6.
Background: PubMed 26915718Tan J, Schofer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia - The RISE study. J Eur Acad Dermatol Venereol. 2016 Mar;30(3):428-34. doi: 10.1111/jdv.13556.
Individual participant dataSharing planned: No. IPD may not be shared because this study is conducted at a VA hospital with a small sample size

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kayla N Zafar, BA contact

718-836-6600 ext. 7023

kayla.zafar@va.gov

Jared Jagdeo, MD MS principal investigator

SUNY Downstate Health Sciences University Department of Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clascoterone Cream 1% in people with Papular-pustular Rosacea and Papulopustular Rosacea (PPR), run by Narrows Institute for Biomedical Research at 1 site in United States.

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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Kayla N Zafar, BA (718-836-6600 ext. 7023, kayla.zafar@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline. (time frame: From enrollment to end of treatment at 12 weeks). 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 NCT06952517, which also lists 6 linked publications.

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 6 May 2025.