Efficacy Study in Patients With Acne Vulgaris.

• Sponsor: Taro Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02935036
• Collaborator: (none)
• Enrollment: 294
• Arms: 2
• Actual Duration (Months): 5.6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Oct 3, 2016
• Actual Primary Completion Date: Jan 24, 2017
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

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 Names: 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 Names: vehicle

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face [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 [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Taro Pharmaceuticals USA

Investigators

• Study Chair: Catawba Research, http://catawbaresearch.com/contact/

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2016

More Information

Publications

None provided.

• Responsible Party: Taro Pharmaceuticals USA
• ClinicalTrials.gov Identifier: NCT02935036
• Other Study ID Numbers: ADPS 1602
• First Posted: Oct 17, 2016
• Last Update Posted: Oct 18, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	ADPS Topical Product	Placebo Control
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

Baseline Characteristics

Arm/Group Title	ADPS Topical Product	Placebo Control	Total
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 Participants	147	147	294
Age (Count of Participants)
<=18 years	57 38.8%	58 39.5%	115 39.1%
Between 18 and 65 years	89 60.5%	83 56.5%	172 58.5%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.1 (8.29)	22.4 (8.7)	22.2 (8.48)
Sex: Female, Male (Count of Participants)
Female	83 56.5%	98 66.7%	181 61.6%
Male	63 42.9%	43 29.3%	106 36.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	75 51%	69 46.9%	144 49%
Not Hispanic or Latino	71 48.3%	72 49%	143 48.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 2.7%	2 1.4%	6 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 27.2%	41 27.9%	81 27.6%
White	101 68.7%	93 63.3%	194 66%
More than one race	1 0.7%	5 3.4%	6 2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	147 100%	147 100%	294 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.210 (6.6911)	26.157 (6.8472)	25.676 (6.7730)

Outcome Measures

1. Primary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ADPS Topical Product	Placebo Control
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
Measure Participants	146	141
Least Squares Mean (95% Confidence Interval) [percentage change in lesion counts]	-60.84	-62.17

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ADPS Topical Product, Placebo Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5947
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.33
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ADPS Topical Product	Placebo Control
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
Measure Participants	146	141
Least Squares Mean (95% Confidence Interval) [percentage change in lesion counts]	-49.91	-52.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ADPS Topical Product, Placebo Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2912
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.75
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ADPS Topical Product	Placebo Control
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
Measure Participants	146	141
Number [Percentage of subjects]	13.0	10.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ADPS Topical Product, Placebo Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6920
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	2.4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/146 (0%)		0/141 (0%)
Serious Adverse Events
	ADPS Topical Product		Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/146 (0%)		1/141 (0.7%)
Product Issues
Spontaneous abortion	0/146 (0%)		1/141 (0.7%)
Other (Not Including Serious) Adverse Events
	ADPS Topical Product		Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/146 (1.4%)		3/141 (2.1%)
Infections and infestations
Nasopharyngitis	2/146 (1.4%)		3/141 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

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.