Acne VulgarisPhase 1NCT03132194
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
A Phase 1 study testing DPSG 7.5% and Aczone in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- DPSG 7.5% and Aczone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,125 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2016to 30 Jan 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
About this study
Official title: A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
Read the detailed description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- DPSG 7.5%, Aczone, 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.
DPSG 7.5%Drug
Also called dapsone
topical gel
AczoneDrug
Also called dapsone
topical gel
PlaceboDrug
Also called Vehicle
topical gel
| Study group | Role | What they receive |
|---|---|---|
| DPSG 7.5% | Experimental | DPSG 7.5% (Taro Pharmaceuticals USA)
Topical, twice daily on the face for 84 days. Receives: Drug: DPSG 7.5% |
| Vehicle Gel | Placebo comparator | Placebo product (Taro Pharmaceuticals Inc.)
Topical, twice daily on the face for 84 days. Receives: Drug: Placebo |
| Aczone | Active comparator | dapsone 7.5
Topical, twice daily on the face for 84 days. Receives: Drug: Aczone |
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
Change in non-inflammatory lesion counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Measured: 12 weeks
Secondary outcomes (1)
Clinical response of success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
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 posted27 Apr 2017
- Study start8 Aug 2016
- Primary completion16 Jan 2017
- Study completion30 Jan 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,125 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
- NCT03132194
- Sponsor's protocol ID
- DPSG-1517
- Status last verified
- May 2017
- First submitted
- 16 Mar 2017
- 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 Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03132194
- Acronym / sponsor ID
- DPSG-1517
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 27 Apr 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.
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
Detailed description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPSG 7.5% | Experimental | Drug: DPSG 7.5%DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days. |
| Vehicle Gel | Placebo comparator | Drug: PlaceboPlacebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days. |
| Aczone | Active comparator | Drug: Aczonedapsone 7.5 Topical, twice daily on the face for 84 days. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
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 |
|---|---|---|
| DPSG 7.5%Also: dapsonetopical gel | Drug | DPSG 7.5% |
| AczoneAlso: dapsonetopical gel | Drug | Aczone |
| PlaceboAlso: Vehicletopical gel | Drug | Vehicle Gel |
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
Change in non-inflammatory lesion counts
Time frame: 12 weeks
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
1 secondary outcome
Clinical response of success
Time frame: 12 weeks
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 DPSG 7.5% and Aczone 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 1 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 counts (time frame: 12 weeks). 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.