]>
IRCT20120909010795N4 IRCT 2020-12-08 Shiraz University of Medical Sciences Fractional CO2 laser and topical latanoprost in acral vitiligo 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 2020-06-21 anticipated 24 Complete https://irct.ir/trial/43378 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: In this double-blind study, patients and physicion are blind. Drug and placebo have codes that decode at the end of the study. N/A Vitiligo. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data about main result of the patient's treatment can be shared. When: 3 months after publishment. To whom: Researchers of academic centers. Conditions: For the same clinical researches. Where to obtain: Email to the researcher. How to obtain: By email or call the researcher, data of this research will be available in about one month. Comments:
public Fatemeh Rahmanian
Faghihi hospital, Department of Dermatology, Zand Blvd.
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 rahmanian.f87@gmail.com Shiraz University of Medical Sciences scientific Nasrin Saki
Faghihi hospital, Department of Dermatology, Zand Blvd.
Shiraz Iran (Islamic Republic of) 713451978 +98 71 3231 9049 sakina@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 14 years no limit Both 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 L80 Vitiligo Treatment - Drugs Treatment - Drugs 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. 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. 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. Shiraz University of Medical Sciences Approved 2019-07-29 Ethics committee of Shiraz University of Medical Sciences Faghihi hospital, Zand Blvd. Shiraz Fars Iran (Islamic Republic of) Approved 2019-07-29 Ethics committee of Shiraz University of Medical Sciences Faghihi hospital, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)