Trial Outcomes & Findings for Comparison of Two Salicylic Acid Formulations (NCT NCT00848744)

Results Overview

Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).

Results posted on

2018-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Salicylic Acid Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Salicylic Acid Formulations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Salicylic Acid n=10 Participants Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Age, Categorical <=18 years	6 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: 28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).

Population: Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.

Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).

Outcome measures

Outcome measures
Measure	Salicylic Acid n=10 Participants Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on	Formulation B n=10 Participants Participants used salicylic acid Formulation A on either the right or left side of the face.
Physician Global Assessment Baseline	2.65 units on a scale Standard Deviation 0.41	2.6 units on a scale Standard Deviation 0.52
Physician Global Assessment Day 2	2.55 units on a scale Standard Deviation 0.44	2.45 units on a scale Standard Deviation 0.55
Physician Global Assessment Day 7	2.4 units on a scale Standard Deviation 0.61	2.3 units on a scale Standard Deviation 0.59
Physician Global Assessment Day 28	2.20 units on a scale Standard Deviation 0.63	2.15 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 4 Weeks

Population: Data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Salicylic Acid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Salicylic Acid n=10 participants at risk Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Skin and subcutaneous tissue disorders irritation and swelling of face	10.0% 1/10 • Number of events 1

Additional Information

Dermatology CTU

Northwestern University

Phone: 312-503-5944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place