PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Vitiligo Clinical Trial

Official title:

PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933774
• Other study ID #: VC18MESI0278
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: August 2020
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Vitiligo is a chronic depigmentation disorder characterized by well-demarcated white macules and patches, reflecting selective melanocyte destruction. Hyperpigmentation at the treated areas is one of the limitations of phototherapy. Topical tretinoin (retinoic acid) has been well established to be effective for skin pigmentary disorders including melasma. This study aims to investigate the preventive effect of topical tretinoin on hyperpigmentation during phototherapy. A randomized controlled trial based on split-face was planned. The left/right face will be randomized to either tretinoin or placebo cream treatment groups. All lesions will be treated using phototherapy twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 29, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Vitiligo

Intervention

Drug:
• Tretinoin 0.05% cream
Stieva-A Cream 0.05%, 25g, GSK
• Placebo cream
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Degree of Hyperpigmentation at 12 Weeks	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.	at 12 weeks
Secondary	Number of Participants Who Showed =75% Repigmentation	Number of Participants who Showed =75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.	change from Baseline and at 12 weeks