Trial Outcomes & Findings for Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris (NCT NCT01209949)

Results Overview

Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-08-01

Participant Flow

Dates of recruitment period: First subject was enrolled on October 7, 2010 and the last subject was enrolled on October 12, 2010. Types of location: Investigative site was located at a research center.

Wash-out period up to baseline was 30 days for topical and systemic acne treatments with the exception of isotretinoin, which had a wash-out period of 4 months.

Participant milestones

Participant milestones
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Study Lost to Follow-up	3

Baseline Characteristics

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel n=30 Participants Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Age, Continuous	17.5 years STANDARD_DEVIATION 1.68 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Modified ITT (subjects with a baseline and week 12 visit)

Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.

Outcome measures

Outcome measures
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel n=27 Participants Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12	18 participants

SECONDARY outcome

Timeframe: Week 12

Population: Modified ITT (subjects with a baseline and week 12 visit)

Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.

Outcome measures

Outcome measures
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel n=27 Participants Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. Inflammatory Lesions	-44.1 percent change from baseline Standard Deviation 34.79
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. Noninflammatory Lesions	-57.1 percent change from baseline Standard Deviation 19.83
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. Total Lesions	-49.7 percent change from baseline Standard Deviation 24.06

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety

Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.

Outcome measures

Outcome measures
Measure	Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel n=30 Participants Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Number of Participants With Tolerability Assessments Resulting in an Adverse Event	2 participants

Adverse Events

Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Norman Preston

Galderma Laboratories, L.P.

Phone: 817-961-5360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
Publication restrictions are in place

Restriction type: OTHER