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Trial record 86 of 233 for:    acne AND Percent

Efficacy Study in Patients With Acne Vulgaris.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02935036
Recruitment Status : Completed
First Posted : October 17, 2016
Results First Posted : September 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
Safety and efficacy study in patients with acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: ADPS topical product Drug: Placebo Control Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : January 24, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: ADPS topical product
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Drug: ADPS topical product
topical product
Other Name: Active

Placebo Comparator: Placebo Control
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Drug: Placebo Control
topical product
Other Name: vehicle




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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.



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935036


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/
  Study Documents (Full-Text)

Documents provided by Taro Pharmaceuticals USA:

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02935036     History of Changes
Other Study ID Numbers: ADPS 1602
First Posted: October 17, 2016    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: October 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases