Trial Outcomes & Findings for PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation (NCT NCT03933774)
NCT ID: NCT03933774
Last Updated: 2020-08-18
Results Overview
The degree of hyperpigmentation will be assessed as L\* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
at 12 weeks
Results posted on
2020-08-18
Participant Flow
This is a split-face trial. A single patient with paired lesions will be enrolled.
Participant milestones
| Measure |
Left Tretinoin 0.05% Cream, Right Placebo
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the left side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the right side of the face for 1 month, applied once a day every night
|
Left Placebo, Right Tretinoin 0.05% Cream
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the right side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the left side of the face for 1 month, applied once a day every night
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Baseline characteristics by cohort
| Measure |
Left Tretinoin 0.05% Cream, Right Placebo
n=12 Participants
The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) was applied on the half side of the face of the patients for 1 month, once a day every night.
|
Left Placebo, Right Tretinoin 0.05% Cream
n=13 Participants
The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Placebo cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) was applied on the other half side of the face of the patients for 1 month, once a day every night.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
12 participants
n=93 Participants
|
13 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
L* value at baseline
|
58.5 score on a scale
n=93 Participants
|
56.7 score on a scale
n=4 Participants
|
57.6 score on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: at 12 weeksThe degree of hyperpigmentation will be assessed as L\* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
Outcome measures
| Measure |
Left Tretinoin 0.05% Cream, Right Placebo
n=10 Participants
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the left side, placebo cream on the right side of the face applied once a day every night
|
Left Placebo, Right Tretinoin 0.05% Cream
n=11 Participants
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the right side, placebo cream on the left side of the face applied once a day every night
|
|---|---|---|
|
The Degree of Hyperpigmentation at 12 Weeks
Tretinoin side
|
56.8 score on a scale
Interval 49.0 to 62.0
|
57.6 score on a scale
Interval 52.0 to 63.0
|
|
The Degree of Hyperpigmentation at 12 Weeks
Placebo side
|
51.0 score on a scale
Interval 46.0 to 60.0
|
54.3 score on a scale
Interval 45.0 to 62.0
|
SECONDARY outcome
Timeframe: change from Baseline and at 12 weeksNumber of Participants who Showed ≥75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.
Outcome measures
| Measure |
Left Tretinoin 0.05% Cream, Right Placebo
n=10 Participants
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the left side, placebo cream on the right side of the face applied once a day every night
|
Left Placebo, Right Tretinoin 0.05% Cream
n=11 Participants
Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the right side, placebo cream on the left side of the face applied once a day every night
|
|---|---|---|
|
Number of Participants Who Showed ≥75% Repigmentation
Tretinoin side
|
8 Participants
|
9 Participants
|
|
Number of Participants Who Showed ≥75% Repigmentation
Placebo side
|
8 Participants
|
9 Participants
|
Adverse Events
Tretinoin 0.05% Cream Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Cream Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tretinoin 0.05% Cream Group
n=25 participants at risk
Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face once a day every night
Tretinoin 0.05% cream: Stieva-A Cream 0.05%, 25g, GSK
|
Placebo Cream Group
n=25 participants at risk
PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half of the face once a day every night
Placebo cream: Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Irritation
|
24.0%
6/25 • Any adverse effects (irritation, burning sensation, etc.) were collected at week 4, week 8, week 12.
|
0.00%
0/25 • Any adverse effects (irritation, burning sensation, etc.) were collected at week 4, week 8, week 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place