Trial Outcomes & Findings for Efficacy Study in Patients With Acne Vulgaris. (NCT NCT02935036)

NCT ID: NCT02935036

Last Updated: 2018-10-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

294 participants

Primary outcome timeframe

Baseline to week 12 (study day 84)

Results posted on

2018-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	ADPS Topical Product A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
Overall Study STARTED	147	147
Overall Study COMPLETED	137	136
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to week 12 (study day 84)

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

Outcome measures

Outcome measures
Measure	ADPS Topical Product n=146 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=141 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face	-60.84 percentage change in lesion counts Interval -64.31 to -57.36	-62.17 percentage change in lesion counts Interval -65.71 to -58.62

PRIMARY outcome

Timeframe: Baseline to week 12 (study day 84)

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

Outcome measures

Outcome measures
Measure	ADPS Topical Product n=146 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=141 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face	-49.91 percentage change in lesion counts Interval -53.53 to -46.3	-52.67 percentage change in lesion counts Interval -56.35 to -48.98

PRIMARY outcome

Timeframe: Baseline to Week 12 (study day 84)

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

Success was defined as an IGA score that was at least two grades less than the baseline assessment.

Outcome measures

Outcome measures
Measure	ADPS Topical Product n=146 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=141 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.	13.0 Percentage of subjects	10.6 Percentage of subjects

Adverse Events

ADPS Topical Product

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Control

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ADPS Topical Product n=146 participants at risk A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=141 participants at risk A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
Product Issues Spontaneous abortion	0.00% 0/146 • 1 year 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.	0.71% 1/141 • 1 year 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.

Other adverse events

Other adverse events
Measure	ADPS Topical Product n=146 participants at risk A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=141 participants at risk A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product
Infections and infestations Nasopharyngitis	1.4% 2/146 • 1 year 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.	2.1% 3/141 • 1 year 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.

Additional Information

Manager, Clinical Research

Taro Pharmaceuticals U.S.A., Inc.

Phone: 9143459001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ADPS Topical Product n=147 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product	Placebo Control n=147 Participants A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product	Total n=294 Participants Total of all reporting groups
Age, Categorical <=18 years	57 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	58 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	115 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Age, Categorical Between 18 and 65 years	89 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	83 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	172 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Age, Categorical >=65 years	0 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Age, Continuous	22.1 years STANDARD_DEVIATION 8.29 • n=147 Participants	22.4 years STANDARD_DEVIATION 8.7 • n=147 Participants	22.2 years STANDARD_DEVIATION 8.48 • n=294 Participants
Sex: Female, Male Female	83 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	98 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	181 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Sex: Female, Male Male	63 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	43 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	106 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Ethnicity (NIH/OMB) Hispanic or Latino	75 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	69 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	144 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	72 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	143 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) Asian	4 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	2 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	6 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) Black or African American	40 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	41 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	81 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) White	101 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	93 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	194 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) More than one race	1 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	5 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	6 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	0 Participants n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.
Region of Enrollment United States	147 participants n=147 Participants	147 participants n=147 Participants	294 participants n=294 Participants
Body Mass Index (BMI)	25.210 kg/m^2 STANDARD_DEVIATION 6.6911 • n=146 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	26.157 kg/m^2 STANDARD_DEVIATION 6.8472 • n=141 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.	25.676 kg/m^2 STANDARD_DEVIATION 6.7730 • n=287 Participants • The analysis population used for demographics excluded some subjects in baseline/randomized population.