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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: ADPS topical product
Drug: Placebo Control
Enrollment 294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ADPS Topical Product Placebo Control
Hide Arm/Group Description

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

Period Title: Overall Study
Started 147 147
Completed 137 136
Not Completed 10 11
Arm/Group Title ADPS Topical Product Placebo Control Total
Hide Arm/Group Description

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
<=18 years 57 58 115
Between 18 and 65 years 89 83 172
>=65 years 0 0 0
[1]
Measure Analysis Population Description: The analysis population used for demographics excluded some subjects in baseline/randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 147 participants 294 participants
22.1  (8.29) 22.4  (8.7) 22.2  (8.48)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
Female
83
  56.8%
98
  69.5%
181
  63.1%
Male
63
  43.2%
43
  30.5%
106
  36.9%
[1]
Measure Analysis Population Description: The analysis population used for demographics excluded some subjects in baseline/randomized population.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
Hispanic or Latino
75
  51.4%
69
  48.9%
144
  50.2%
Not Hispanic or Latino
71
  48.6%
72
  51.1%
143
  49.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   2.7%
2
   1.4%
6
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
40
  27.4%
41
  29.1%
81
  28.2%
White
101
  69.2%
93
  66.0%
194
  67.6%
More than one race
1
   0.7%
5
   3.5%
6
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: The analysis population used for demographics excluded some subjects in baseline/randomized population.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants 147 participants 294 participants
147 147 294
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 146 participants 141 participants 287 participants
25.210  (6.6911) 26.157  (6.8472) 25.676  (6.7730)
[1]
Measure Analysis Population Description: The analysis population used for demographics excluded some subjects in baseline/randomized population.
1.Primary Outcome
Title Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
Hide Description [Not Specified]
Time Frame Baseline to week 12 (study day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for efficacy excluded some subjects in baseline/randomized population.
Arm/Group Title ADPS Topical Product Placebo Control
Hide Arm/Group Description:

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

Overall Number of Participants Analyzed 146 141
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage change in lesion counts
-60.84
(-64.31 to -57.36)
-62.17
(-65.71 to -58.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADPS Topical Product, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5947
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.33
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
Hide Description [Not Specified]
Time Frame Baseline to week 12 (study day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for efficacy excluded some subjects in baseline/randomized population.
Arm/Group Title ADPS Topical Product Placebo Control
Hide Arm/Group Description:

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

Overall Number of Participants Analyzed 146 141
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage change in lesion counts
-49.91
(-53.53 to -46.30)
-52.67
(-56.35 to -48.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADPS Topical Product, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2912
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.75
Estimation Comments [Not Specified]
3.Primary Outcome
Title The Percentage of Subjects With a Clinical Response (IGA) of “Success” at Week 12 on the Face.
Hide Description Success was defined as an IGA score that was at least two grades less than the baseline assessment.
Time Frame Baseline to Week 12 (study day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for efficacy excluded some subjects in baseline/randomized population.
Arm/Group Title ADPS Topical Product Placebo Control
Hide Arm/Group Description:

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

Overall Number of Participants Analyzed 146 141
Measure Type: Number
Unit of Measure: Percentage of subjects
13.0 10.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADPS Topical Product, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6920
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent difference
Estimated Value 2.4
Estimation Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description An adverse event was defined as "Any untoward medical occurrence in a Subject or clinical-trial Subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment", not any untoward or unfavorable medical occurrence in a participant " temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research" as defined by clinicaltrials.gov.
 
Arm/Group Title ADPS Topical Product Placebo Control
Hide Arm/Group Description

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product

A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

Placebo Control: topical product

All-Cause Mortality
ADPS Topical Product Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   0/141 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ADPS Topical Product Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   1/141 (0.71%) 
Product Issues     
Spontaneous abortion   0/146 (0.00%)  1/141 (0.71%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ADPS Topical Product Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   2/146 (1.37%)   3/141 (2.13%) 
Infections and infestations     
Nasopharyngitis   2/146 (1.37%)  3/141 (2.13%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Manager, Clinical Research
Organization: Taro Pharmaceuticals U.S.A., Inc.
Phone: 9143459001
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02935036     History of Changes
Other Study ID Numbers: ADPS 1602
First Submitted: October 12, 2016
First Posted: October 17, 2016
Results First Submitted: August 21, 2018
Results First Posted: September 18, 2018
Last Update Posted: October 18, 2018