Trial Outcomes & Findings for Apremilast in the Treatment of Moderate to Severe Acne (NCT NCT01074502)

Results Overview

RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Apremilast apremilast 20 mgs twice a day for 12 weeks
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Apremilast apremilast 20 mgs twice a day for 12 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Apremilast in the Treatment of Moderate to Severe Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apremilast n=3 Participants apremilast 20 mgs twice a day for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: small number of subjects to analyze

RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: small number of subjects to be analyzed

RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Number of participants with adverse events

Outcome measures

Outcome data not reported

Adverse Events

Apremilast

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

Aida Lugo-Somolinos MD-PI

UNC Chapel Hill

Phone: 919-843-9447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place