Vitiligo is a common pigmentary disorder with great cosmetic, psychological morbidity and an unpredictable course. Unstable vitiligo is one of the main challenges treatment. After determining the sample size cases are selected from the patients with unstable vitiligo. Patients were randomly divided into two groups, and each group underwent three months of treatment with Minocycline or NBUVB. NBUVB group received NBUVB therapy twice a week and Minocycline group received Minocycline 100 mg once a daily. Both groups also treated with folic acid 5 mg daily, triamcinolone cream for face, groin, axilla and genital areas and clobetasol cream for other areas. At the end of the study, data review and analysis with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122315246N2
Registration date:2014-01-10, 1392/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-10, 1392/10/20
Registrant information
Name
Kioumars Jamshidi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1777 2134
Email address
kioumars_jamshidi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-07-12, 1391/04/22
Expected recruitment end date
2014-01-18, 1392/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
NBUVB versus minocycline in vitiligo stabiling in unstable vitiligo
Public title
Comparison of therapeutic effects of minocycline versus light therapy in vitiligo treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: unstable Vitiligo with 20- 50% body surface area involvement.
Exclusion criteria: age ≤ 8 years or ≥50 years old; pregnancy or intention to become pregnant; breastfeeding; other severe systemic diseases e.g. cardiovascular, renal and hepatic failure; segmental vitiligo; acral vitiligo taking any other vitiligo treatment; history of having taken any medication that could interact with minocycline within the previous 3 months; history of photo-mediated disorders such as systemic lupus erythematous and xeroderma pigmentosa (XP) etc; known hypersensitivity to the study medication.
Age
From 8 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahanl University of medical science
Street address
Deputy of research of isfahan university of medical science, hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
391262
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
vitiligo
Primary outcomes
1
Description
Vitiligo stability
Timepoint
0, 1st, 2nd, 3rd months
Method of measurement
Vitiligo disease activity score (VIDA)
Secondary outcomes
1
Description
Side effects of drug
Timepoint
End of first, second and third month of treatment
Method of measurement
Examination
Intervention groups
1
Description
group 1:
capsule minocycline 100 mg daily for 3 months
Category
Treatment - Drugs
2
Description
Group 2: NBUVB twice per week with 311 nm Wavelength, irradiance 1800–2000 μ W/cm 2 for 3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital of dermatology clinic
Full name of responsible person
Hospital dermatology clinic of alzahra
Street address
dermatology group,Alzahra hospital,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Medical University
Full name of responsible person
Dr. Ebrahim Esfandiari
Street address
Isfahan University of Medical Sciiences, Hezar jerib Avne
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?