Trial Outcomes & Findings for Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women (NCT NCT00616239)

Last Updated: 2020-08-10

Results Overview

Improvement of melasma on the peel side using mexameter reading

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

14 weeks

Results posted on

2020-08-10

Participant milestones
Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
Overall Study Withdrawal by Subject	2

Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

Baseline characteristics by cohort
Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream n=20 Participants Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: 14 weeks

Improvement of melasma on the peel side using mexameter reading

Outcome measures
Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream n=18 Participants Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
Number of Participants Showing Improvement of Melasma Based on Mexameter Readings	18 participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream n=20 participants at risk Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
Skin and subcutaneous tissue disorders Erythema	20.0% 4/20 • Number of events 4 • Adverse event data was collected over the duration of the study, ie; from screening till the last day of the follow up period, an average of 14 weeks.
Skin and subcutaneous tissue disorders Burning	20.0% 4/20 • Number of events 4 • Adverse event data was collected over the duration of the study, ie; from screening till the last day of the follow up period, an average of 14 weeks.
Skin and subcutaneous tissue disorders Peeling	20.0% 4/20 • Number of events 4 • Adverse event data was collected over the duration of the study, ie; from screening till the last day of the follow up period, an average of 14 weeks.

UT Southwestern Medical Center at Dallas

Phone: 214-645-8300