The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

Vitiligo Vulgaris Clinical Trial

Official title:

The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03234673
• Other study ID #: TEOPFCLEWTCOWNITTOSGV
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 27, 2017
• Last updated: July 30, 2017
• Start date: August 2017
• Est. completion date: January 2019

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: yasmin tawfik, MD
• Phone: 01006033331
• Email: dr.yasminmostawfik[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009).

Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).

Description:

Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).

Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with stable vitiligo

• nonsegmental vitiligo will be recruited

• A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year

Exclusion Criteria:

1. Patients with active infection.

2. Reported histories of koebnerization.

3. History of keloid formation or hypertrophic scars.

4. Pregnant or lactating females.

5. Bleeding tendency.

Related Conditions & MeSH terms

• Vitiligo
• Vitiligo Vulgaris

Intervention

Drug:
• Tacrolimus ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
• calcipotriol ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
• NB-UVB
3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8. Review. — View Citation

Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15. Review. — View Citation

Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944. — View Citation

Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- Frequency and types of side effects.	pain, scarring, hyperpigmentation	3 months
Other	- Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:	dissatisfied; neutral; somewhat satisfied; moderately satisfied; very satisfied	3 months
Primary	1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).	G0, < 25% repigmentation (poor); G1, 25-50% repigmentation (fair); G2, 50-75% repigmentation (good); G3 > 75% repigmentation (excellent).	up to 3 months
Secondary	The VASI percent change	The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.	every month for 3 months