Acne VulgarisPhase 2NCT02935036

Efficacy Study in Patients With Acne Vulgaris.

A Phase 2 study testing ADPS topical product in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety and efficacy study in patients with acne vulgaris Read more about this study

Who is it for?: Ages 9 years and olderHealthy volunteers can take part
Conditions the study is for: Acne Vulgaris
What is being tested?: ADPS topical product
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 294 participants
Where: No sites listed yet
Study dates: 3 Oct 2016to 21 Mar 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 9 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Healthy male or non pregnant female aged ≥ 9 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 Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris

Safety and efficacy study in patients with acne vulgaris

Read the detailed description

randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Conditions: Acne Vulgaris
Being tested: ADPS topical product, Placebo Control
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADPS topical productDrug
Also called Active
topical product
Placebo ControlDrug
Also called vehicle
topical product

Study groups in NCT02935036
Study group	Role	What they receive
ADPS topical product	Experimental	A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Receives: Drug: ADPS topical product
Placebo Control	Placebo comparator	A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Receives: Drug: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
Measured: Baseline to week 12 (study day 84)
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
Measured: Baseline to week 12 (study day 84)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
Success was defined as an IGA score that was at least two grades less than the baseline assessment.
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.

3 Oct 201621 Mar 2017

First posted17 Oct 2016 (estimated)
Study start3 Oct 2016
Primary completion24 Jan 2017
Study completion21 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02935036
Sponsor's protocol ID: ADPS 1602
Status last verified: Sep 2018
First submitted: 12 Oct 2016
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. 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 to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT02935036
Acronym / sponsor ID: ADPS 1602
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: 3 Oct 2016 (actual)
Primary completion: 24 Jan 2017 (actual)
Study completion: 21 Mar 2017 (actual)
First posted: 17 Oct 2016 (estimated)
Results: Posted 18 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety and efficacy study in patients with acne vulgaris

Detailed description

randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS 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: 2

Arm	Type	Receives
ADPS topical product	Experimental	Drug: ADPS topical productA thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Placebo Control	Placebo comparator	Drug: Placebo ControlA thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Healthy male or non pregnant female aged ≥ 9 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
ADPS topical productAlso: Activetopical product	Drug	ADPS topical product
Placebo ControlAlso: vehicletopical product	Drug	Placebo Control

Primary outcome

Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
Time frame: Baseline to week 12 (study day 84)
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
Time frame: Baseline to week 12 (study day 84)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
Time frame: Baseline to Week 12 (study day 84)
Success was defined as an IGA score that was at least two grades less than the baseline assessment.

Results and safety

Results posted to the registry on 18 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADPS Topical Product	147	137
Placebo Control	147	136

Primary outcome: Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face

Time frame: Baseline to week 12 (study day 84). Least squares mean (95% Confidence Interval). Unit: percentage change in lesion counts

Measure	ADPS Topical Product n = 146	Placebo Control n = 141
Value	-60.84 (-64.31 to -57.36)	-62.17 (-65.71 to -58.62)

ADPS Topical Product vs Placebo Control: LS Mean Difference: 1.33, p = 0.5947, ANOVA

Population analysed: The analysis population for efficacy excluded some subjects in baseline/randomized population.

Primary outcome: Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face

Time frame: Baseline to week 12 (study day 84). Least squares mean (95% Confidence Interval). Unit: percentage change in lesion counts

Measure	ADPS Topical Product n = 146	Placebo Control n = 141
Value	-49.91 (-53.53 to -46.30)	-52.67 (-56.35 to -48.98)

ADPS Topical Product vs Placebo Control: LS Mean Difference: 2.75, p = 0.2912, ANOVA

Population analysed: The analysis population for efficacy excluded some subjects in baseline/randomized population.

Primary outcome: The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.

Time frame: Baseline to Week 12 (study day 84). Number. Unit: Percentage of subjects

Measure	ADPS Topical Product n = 146	Placebo Control n = 141
Value	13.0	10.6

ADPS Topical Product vs Placebo Control: Percent difference: 2.4, p = 0.6920, Cochran-Mantel-Haenszel

Population analysed: The analysis population for efficacy excluded some subjects in baseline/randomized population.

Adverse events

Time frame: 1 year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADPS Topical Product	0 of 146 (0%)	2 of 146 (1.4%)	0 of 146
Placebo Control	1 of 141 (0.7%)	3 of 141 (2.1%)	0 of 141

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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 2 study testing ADPS topical product 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 18 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face (time frame: Baseline to week 12 (study day 84)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935036.

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 18 Oct 2018.