Comparison of the efficacy of topical latanoprost and fractional CO2 laser with placebo and fractional CO2 laser in treatment of vitiligo with acral involvement, phototherapy unit, Faghihi hospital, Shiraz, 2020
Comparison the effect of fractional CO2 laser and topical latanoprost with laser and placebo in acral vitiligo in patients on phototherapy
Design
In this double-blind control trial, vitiligo patients with bilateral acral lesions that are on phototherapy, randomly used latanoprost eye drop or placebo on each side after CO2 fractional laser. Laser will be done every two weeks and drug and placebo apply by patient twice daily for one week post laser. Drug and placebo are coded in same boxes and uncode at the end of the study. Every sessions before laser, photographes were taken and side effects recorded. VASI score and VAS are used for assessment.
Settings and conduct
At Emam Reza clinic, dermatology unit, 24 acral vitiligo patiantes were included in this double blind control trial study, by treatment with latanoprost and placebo and fractional CO2 laser.
Participants/Inclusion and exclusion criteria
Patients have age 14 or more with symmetrical vitiligo patches, receiving phototherapy (NB-UVB, PUVA). Patients discontinued all their systemic or topical vitiligo treatments for one month. Patients with a history of allergy to prostaglandins, pregnant or breast-feeding women, uncontrolled systemic disorders and history of keloids were excluded.
Intervention groups
In case group, patients apply latanoprost 0.005% eye drop after fractional laser and control group apply placebo after laser.
Main outcome variables
Qualitative assessment with VASI score and VAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120909010795N4
Registration date:2020-12-08, 1399/09/18
Registration timing:retrospective
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Nasrin Saki
Name of organization / entity
Dermatology Department,Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 19049
Email address
sakina@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2020-11-21, 1399/09/01
Trial completion date
2020-11-21, 1399/09/01
Scientific title
Comparison of the efficacy of topical latanoprost and fractional CO2 laser with placebo and fractional CO2 laser in treatment of vitiligo with acral involvement, phototherapy unit, Faghihi hospital, Shiraz, 2020
Public title
Fractional CO2 laser and topical latanoprost in acral vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 14
Acral vitiligo patche(s) resistant to phototherap
Discontinue all systemic and topical treatments for 1 month
At least 1 lesion in each side with size of 2*2 to 8*8 cm
Exclusion criteria:
Poor compliance
Allergy to latanoprost
Pregnant or breast-feeding women
Age before 14
Uncontrolled systemic disorders that interfere with wound healing process
Autoimmune disorders
History of allergy to any drug
Any psychological disorders
Unilateral lesions
Active infection at laser site
History of keloids
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral symmetrical acrl patches
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
2
Bilateral symmetrical acrl patches
Randomization (investigator's opinion)
Randomized
Randomization description
A lesion in each side selected and randomly (blocked randomization) assigned to receive latanoprost or placebo: one side received fractional CO2 laser followed 0.005% solution of latanoprost, and the other side fractional CO2 laser and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients and physicion are blind. Drug and placebo have codes that decode at the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faghihi hospital, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71348846114
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.SUMS.MED.REC.1398.312
2
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faghihi hospital, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71348846114
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.SUMS.MED.REC.1398.312
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Skin pigmentation
Timepoint
At the beginning of study and after 5 sessions of laser therapy, at the end of the study
Method of measurement
Qualitative assessment with VASI score and VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 24 vitiligo patients with bilateral symmetrical lesions, on phototherapy, on one side took CO2 fractional laser (Microxel, MX7000, Korea) with energy level of 22 to 24 mJ, repeat time of 500ms, for 2 to 3 passes, every two weeks. In the first week post laser, they apply latanoprost eye drop 0.005% soution (Sina daruo), two times a day at laser site.
Category
Treatment - Drugs
2
Description
Control group: 24 vitiligo patients with bilateral symmetrical lesions, on phototherapy, on one side took CO2 fractional laser (Microxel, MX7000, Korea) with energy level of 22 to 24 mJ, repeat time of 500ms, for 2 to 3 passes, every two weeks. In the first week post laser, they apply placebo two times a day at laser site.