Trial Outcomes & Findings for Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH) (NCT NCT01038869)

Results Overview

IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2012-09-25

Participant Flow

Subjects recruited from private office population.

Participant milestones

Participant milestones
Measure	Finacea Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
Overall Study STARTED	20
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Finacea Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	6

Baseline Characteristics

Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Finacea n=20 Participants Open label pilot study
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	24 years STANDARD_DEVIATION 10.63 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: Per protocol

IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.

Outcome measures

Outcome measures
Measure	Azelaic Acid 15% Open Label n=20 Participants Assessments of IGA
Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)	92 percentage of participants

SECONDARY outcome

Timeframe: Baseline to16 weeks

Population: per protocol

IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement

Outcome measures

Outcome measures
Measure	Azelaic Acid 15% Open Label n=20 Participants Assessments of IGA
Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: per protocol

The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%

Outcome measures

Outcome measures
Measure	Azelaic Acid 15% Open Label n=20 Participants Assessments of IGA
Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution 2 grade improvement	92 percentage of participants
Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution 1 grade improvement	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: per protocol

Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).

Outcome measures

Outcome measures
Measure	Azelaic Acid 15% Open Label n=20 Participants Assessments of IGA
Percentage Change in Total Lesion Counts	-92.4 percentage of total lesion count Standard Deviation 10.4

SECONDARY outcome

Timeframe: 16 weeks

Population: per protocol

Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus

Outcome measures

Outcome measures
Measure	Azelaic Acid 15% Open Label n=20 Participants Assessments of IGA
Tolerability Assessments as Measured by the Number of Participants With Side Effects	0 participants

Adverse Events

Finacea

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

Leon Kircik, M.D.

DermResearch, PLLC

Phone: 502-451-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place