N/A
N=25
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT03933774 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: The Degree of Hyperpigmentation at 12 Weeks — 56.8; 57.6; 51.0; 54.3 score on a scale — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tretinoin 0.05% cream (Drug); Placebo cream (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- The Catholic University of Korea
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Degree of Hyperpigmentation at 12 Weeks |
56.8; 57.6; 51.0; 54.3 | 0.002 sig |
| SECONDARY Number of Participants Who Showed ≥75% Repigmentation |
8; 9; 8; 9 | 0.479 |
Summary
A randomized controlled split-face pilot study was planned to investigate the preventive effect of tretinoin 0.05% cream on hyperpigmentation during phototherapy in patients with vitiligo.
Eligibility Criteria
Inclusion Criteria
- Age: older than 19
- A patient with stable non-segmental vitiligo
- A patient with symmetrical vitiligo lesions on face
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.
Exclusion Criteria
- Age: lower than 20
- A pregnant or lactating patient
- A patient with active or spreading vitiligo
- A patient who cannot understand the study or who does not sign the informed consent
- Women of childbearing potential not using an effective method of contraception properly
Data sourced from ClinicalTrials.gov (NCT03933774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.