Phototherapy Combination With Topicals in Vitiligo

Vitiligo, Generalized Clinical Trial

— NBUVB  

Official title:

Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04440371
• Other study ID #: 21/104/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2022
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be included in a randomized controlled clinical trial, will enroll only adult vitiligo patients with surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo.

Description:

Patients to be included in this randomized controlled study are adults with generalized vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo. In our going study, adult patients will be enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3 sessions per week in combination with one of the following randomly; one group will start on Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol & betamethasone containing cream once daily, photos will be taken and the exact sites involved will be detected, efficacy of treatment will be assessed according to repigmentation percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months compared to baseline will be classified into 5 groups according to the percentage of repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal (1%-25%); or no response.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult patients ( = 18 years).

• Diagnosed with vitiligo clinically and by using wood's light

• Generalized type vitiligo and BSA = 10%

• Planned by his physician to start on phototherapy

• Wash off period for patients on treatment of one month duration.

Exclusion criteria:

• Children less than 18 year old

• Localized type vitiligo or BSA less than 10%

• Unable to do phototherapy

• Pregnant women with vitiligo

• Previously failed to response to phototherapy

Related Conditions & MeSH terms

• Vitiligo
• Vitiligo, Generalized

Intervention

Combination Product:
• Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly
Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
• Calcipotriol/Betamethasone ointment plus NBUVB
Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly

Locations

Country	Name	City	State
Jordan	Diala Alshiyab	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA) at baseline. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken .	Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
Primary	Efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA) at 3 months. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.	3 months post treatment
Primary	Efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA). the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.	6 months post treatment