RosaceaPhase 1NCT03689010
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea
A Phase 1 study testing Azelaic acid foam 15% and Finacea® (Azelaic acid Foam) 15% in people with Rosacea, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Azelaic acid foam 15% and Finacea® (Azelaic acid Foam) 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,116 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 28 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
- Subjects must have provided IRB approved written informed consent.
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catawba Research, LLC
Charlotte, North Carolina, 28217
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
Read the detailed description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.
- Conditions
- Rosacea
- Being tested
- Azelaic acid foam 15%, Finacea® (Azelaic acid Foam) 15%, Vehicle of the test product
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic acid foam 15%Drug
Also called AZAF 1703
Azelaic acid foam 15%
Finacea® (Azelaic acid Foam) 15%Drug
Azelaic acid foam 15%
Vehicle of the test productDrug
Also called Placebo
Vehicle of the test product
| Study group | Role | What they receive |
|---|---|---|
| Azelaic acid foam 15% | Active comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Receives: Drug: Azelaic acid foam 15% |
| Finacea® (azelaic acid) Foam, 15% | Active comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Receives: Drug: Finacea® (Azelaic acid Foam) 15% |
| Vehicle of the test product | Placebo comparator | Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Receives: Drug: Vehicle of the test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the inflammatory lesion counts
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start12 Dec 2017
- Primary completion9 Aug 2018
- Study completion28 Sep 2018
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
- 1,116 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, Taro Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689010
- Sponsor's protocol ID
- AZAF-1703
- Status last verified
- Mar 2019
- First submitted
- 21 Sep 2018
- Last updated
- 19 Mar 2019
- 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 19 Mar 2019. 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 Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea
- ClinicalTrials.gov ID
- NCT03689010
- Acronym / sponsor ID
- AZAF-1703
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 28 Sep 2018 (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 superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
Detailed description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azelaic acid foam 15% | Active comparator | Drug: Azelaic acid foam 15%Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
| Finacea® (azelaic acid) Foam, 15% | Active comparator | Drug: Finacea® (Azelaic acid Foam) 15%Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
| Vehicle of the test product | Placebo comparator | Drug: Vehicle of the test productTopical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
- Subjects must have provided IRB approved written informed consent.
Key exclusion criteria (2 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
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 |
|---|---|---|
| Azelaic acid foam 15%Also: AZAF 1703Azelaic acid foam 15% | Drug | Azelaic acid foam 15% |
| Finacea® (Azelaic acid Foam) 15%Azelaic acid foam 15% | Drug | Finacea® (azelaic acid) Foam, 15% |
| Vehicle of the test productAlso: PlaceboVehicle of the test product | Drug | Vehicle of the test product |
Primary outcome
change in the inflammatory lesion counts
Time frame: 12 weeks
Percent change from baseline to Week 12 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 19 Mar 2019.
- 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
Taro Pharmaceuticals
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 Azelaic acid foam 15% and Finacea® (Azelaic acid Foam) 15% 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 2 inclusion and 2 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 19 Mar 2019. 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?
change in the inflammatory lesion counts (time frame: 12 weeks). 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 19 Mar 2019.