RosaceaPhase 1NCT03094403
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
A Phase 1 study testing Azelaic Acid 15% topical gel and Finacea® (azelaic acid) Gel, 15% in people with Rosacea, run by Sun Pharmaceutical Industries, Inc..
Trial summary
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study 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 15% topical gel and Finacea® (azelaic acid) Gel, 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Apr 2017
- 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 ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
- Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE
Who cannot join
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
Read the detailed description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
- Conditions
- Rosacea
- Being tested
- Azelaic Acid 15% topical gel, Finacea® (azelaic acid) Gel, 15%, Placebo
- 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 15% topical gelDrug
Also called Azelaic Acid
Gel
Finacea® (azelaic acid) Gel, 15%Drug
Also called Azelaic Acid
Gel
PlaceboDrug
Also called Vehicle
Gel
| Study group | Role | What they receive |
|---|---|---|
| Azelaic Acid 15% topical gel | Experimental | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face Receives: Drug: Azelaic Acid 15% topical gel |
| Finacea® (azelaic acid) Gel, 15% | Active comparator | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face Receives: Drug: Finacea® (azelaic acid) Gel, 15% |
| Placebo | Placebo comparator | Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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 posted29 Mar 2017
- Study start1 Jul 2016
- Primary completion31 Mar 2017
- Study completion1 Apr 2017
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
- Model description
- Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catawba Research, Study chair, http://catawbaresearch.com/contact/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094403
- Sponsor's protocol ID
- AZAG 1533
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2017
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. 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 Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.
- ClinicalTrials.gov ID
- NCT03094403
- Acronym / sponsor ID
- AZAG 1533
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 29 Mar 2017 (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.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
Detailed description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively
| Arm | Type | Receives |
|---|---|---|
| Azelaic Acid 15% topical gel | Experimental | Drug: Azelaic Acid 15% topical gelTopical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
| Finacea® (azelaic acid) Gel, 15% | Active comparator | Drug: Finacea® (azelaic acid) Gel, 15%Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
| Placebo | Placebo comparator | Drug: PlaceboTopically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face |
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 ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
- Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE
Key exclusion criteria (1 listed)
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
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 15% topical gelAlso: Azelaic AcidGel | Drug | Azelaic Acid 15% topical gel |
| Finacea® (azelaic acid) Gel, 15%Also: Azelaic AcidGel | Drug | Finacea® (azelaic acid) Gel, 15% |
| PlaceboAlso: VehicleGel | Drug | Placebo |
Primary outcome
Change in 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 10 Apr 2024.
- 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.
Catawba Research study chair
http://catawbaresearch.com/contact/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azelaic Acid 15% topical gel and Finacea® (azelaic acid) Gel, 15% in people with Rosacea, run by Sun Pharmaceutical Industries, Inc..
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 1 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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 10 Apr 2024.