Acne VulgarisPhase 1NCT02929719
Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
A Phase 1 study testing Test. and Aczone Gel 5% in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
Therapeutic equivalence and safety study Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Test. and Aczone Gel 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,134 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2016
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)
Who cannot join
- Female Subjects who are 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 Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
Therapeutic equivalence and safety study
Read the detailed description
To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).
To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.
To compare the safety of Test, Reference and Placebo treatments.
- Conditions
- Acne Vulgaris
- Being tested
- Test., Aczone Gel 5%, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test.Drug
Also called dapsone
gel
Aczone Gel 5%Drug
Also called dapsone
gel
PlaceboDrug
Also called Vehicle
gel
| Study group | Role | What they receive |
|---|---|---|
| Test Gel 5% | Experimental | Topical, twice daily on the face for 84 days. Receives: Drug: Test. |
| ACZONE Gel 5% | Active comparator | Topical, twice daily on the face for 84 days Receives: Drug: Aczone Gel 5% |
| Placebo Gel | Placebo comparator | Topical, twice daily on the face for 84 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count
Measured: baseline to week 12 (study day 84)
Change in non-inflammatory lesion count
Measured: baseline to week 12 (study day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,134 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
- NCT02929719
- Sponsor's protocol ID
- DPSG 1518, 1216
- Status last verified
- May 2017
- First submitted
- 8 Oct 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. 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 Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02929719
- Acronym / sponsor ID
- DPSG 1518, 1216
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Oct 2016 (estimated)
- 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.
Therapeutic equivalence and safety study
Detailed description
To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).
To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.
To compare the safety of Test, Reference and Placebo treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Gel 5% | Experimental | Drug: Test.Topical, twice daily on the face for 84 days. |
| ACZONE Gel 5% | Active comparator | Drug: Aczone Gel 5%Topical, twice daily on the face for 84 days |
| Placebo Gel | Placebo comparator | Drug: PlaceboTopical, twice daily on the face for 84 days |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)
Key exclusion criteria (1 listed)
- Female Subjects who are 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 |
|---|---|---|
| Test.Also: dapsonegel | Drug | Test Gel 5% |
| Aczone Gel 5%Also: dapsonegel | Drug | ACZONE Gel 5% |
| PlaceboAlso: Vehiclegel | Drug | Placebo Gel |
Primary outcome
Change in inflammatory lesion count
Time frame: baseline to week 12 (study day 84)
Change in non-inflammatory lesion count
Time frame: baseline to week 12 (study day 84)
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 4 May 2017.
- 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 Test. and Aczone Gel 5% in people with Acne Vulgaris, 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 4 May 2017. 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 count (time frame: baseline to week 12 (study day 84)). The study lists 2 primary outcomes in all. 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 4 May 2017.