Phase 2 N=294 Randomized Quadruple-blind Treatment

Efficacy Study in Patients With Acne Vulgaris.

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT02935036 ↗

Enrolled (actual)

294

Serious AEs

0.4%

Results posted

Sep 2018

Primary outcome: Primary: Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face — -60.84; -62.17 percentage change in lesion counts — p=0.5947

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ADPS topical product (Drug); Placebo Control (Drug)
Age: Pediatric, Adult, Older Adult · 9+ yrs
Sex: All
Sponsor: Sun Pharmaceutical Industries, Inc.
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face	-60.84; -62.17	0.5947
PRIMARY Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face	-49.91; -52.67	0.2912
PRIMARY The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.	13.0; 10.6	0.6920

Summary

Safety and efficacy study in patients with acne vulgaris

Eligibility Criteria

Inclusion Criteria

Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris

Exclusion Criteria

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02935036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.