RosaceaPhase 1NCT07795567
A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
A Phase 1 study testing Ivermectin Cream 1%, Soolantra™ Cream 1% and PrRosiver® Cream 1% in people with Rosacea, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Ivermectin Cream 1%, Soolantra™ Cream 1% and PrRosiver® Cream 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 865 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 24 Jun 2026
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial papulopustular rosacea.
- Subjects must have provided IRB approved written informed consent.
- Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (see Table 1 in the section 6.1)
- Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts).
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol, or any of the study medication ingredients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of facial rosacea (e.g., on the face: rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, \& acne vulgaris).
- Subjects who currently have or have recently had bacterial folliculitis on the face
Trial locations and contacts
1 site in 1 country.
United States1 site
Sun Pharmaceutical Industries, Inc.
Hawthorne, New York, 10532
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Ivermectin Cream 1% (Taro Pharmaceutical Industries, Inc.) To Soolantra™ Cream 1% (US Reference Listed Drug), PrRosiver® Cream 1% (Canadian Reference Product), and Each Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea.
Read the detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ivermectin Cream 1%, to Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea.
- Conditions
- Rosacea
- Being tested
- Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1%, Placebo Control
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Cream 1%Drug
Also called Test Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Soolantra™ Cream 1%Drug
Also called Reference Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
PrRosiver® Cream 1%Drug
Also called Reference Product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Placebo ControlDrug
Also called Vehicle of the test product
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin Cream 1% | Experimental | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. Receives: Drug: Ivermectin Cream 1% |
| Soolantra™ Cream 1% | Active comparator | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. Receives: Drug: Soolantra™ Cream 1% |
| PrRosiver® Cream 1% | Active comparator | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. Receives: Drug: PrRosiver® Cream 1% |
| Placebo Control | Placebo comparator | The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product
Percent change in the inflammatory (papules and pustules) lesion counts
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start9 Dec 2025
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Yantovskiy, Study director, Sun Pharmaceuticals Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795567
- Sponsor's protocol ID
- IVRC-2502
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Ivermectin Cream 1% (Taro Pharmaceutical Industries, Inc.) To Soolantra™ Cream 1% (US Reference Listed Drug), PrRosiver® Cream 1% (Canadian Reference Product), and Each Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
- ClinicalTrials.gov ID
- NCT07795567
- Acronym / sponsor ID
- IVRC-2502
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 31 Aug 2026 (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.
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea.
Detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ivermectin Cream 1%, to Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ivermectin Cream 1% | Experimental | Drug: Ivermectin Cream 1%The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
| Soolantra™ Cream 1% | Active comparator | Drug: Soolantra™ Cream 1%The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
| PrRosiver® Cream 1% | Active comparator | Drug: PrRosiver® Cream 1%The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
| Placebo Control | Placebo comparator | Drug: Placebo ControlThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial papulopustular rosacea.
- Subjects must have provided IRB approved written informed consent.
- Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (see Table 1 in the section 6.1)
- Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts).
Key exclusion criteria (4 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol, or any of the study medication ingredients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of facial rosacea (e.g., on the face: rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, \& acne vulgaris).
- Subjects who currently have or have recently had bacterial folliculitis on the face
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 |
|---|---|---|
| Ivermectin Cream 1%Also: Test ProductThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. | Drug | Ivermectin Cream 1% |
| Soolantra™ Cream 1%Also: Reference ProductThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. | Drug | Soolantra™ Cream 1% |
| PrRosiver® Cream 1%Also: Reference ProductThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. | Drug | PrRosiver® Cream 1% |
| Placebo ControlAlso: Vehicle of the test productThe investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days. | Drug | Placebo Control |
Primary outcome
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product
Time frame: Baseline to Week 12
Percent change in the inflammatory (papules and pustules) lesion counts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Natalie Yantovskiy study director
Sun Pharmaceuticals Industries, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivermectin Cream 1%, Soolantra™ Cream 1% and PrRosiver® Cream 1% in people with Rosacea, run by Sun Pharmaceutical Industries, Inc. 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 4 inclusion and 4 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 31 Aug 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.