The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo
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|ClinicalTrials.gov Identifier: NCT03234673|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : August 1, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo Vulgaris||Drug: Tacrolimus ointment Drug: calcipotriol ointment Drug: NB-UVB||Phase 1|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo|
|Estimated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Group A (Tacrolimus group):
fractional CO2 laser therapy and Tacrolimus ointment 1
Drug: Tacrolimus ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
Other Name: tarolimus ointment
Experimental: Group B (Calcipotriol group):
fractional CO2 laser therapy and Calcipotriol ointment
Drug: calcipotriol ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
Other Name: calcipoheal
Experimental: Group C (NB-UVB group):
fractional CO2 laser therapy and NB-UVB twice weekly
3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
Other Name: narrow band ultraviolet rays B
- 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016). [ Time Frame: up to 3 months ]
G0, < 25% repigmentation (poor)
- G1, 25-50% repigmentation (fair)
- G2, 50-75% repigmentation (good)
- G3 > 75% repigmentation (excellent).
- The VASI percent change [ Time Frame: every month for 3 months ]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.
- - Frequency and types of side effects. [ Time Frame: 3 months ]pain, scarring, hyperpigmentation
- - Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction: [ Time Frame: 3 months ]
- somewhat satisfied
- moderately satisfied
- very satisfied
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234673
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