Assessing effectiveness of adding topical atorvastatin to vitiligo treatment

Phase 2

• Conditions: Vitiligo.; Vitiligo

• Registration Number: IRCT20200714048099N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A diagnosis of non-segmental vitiligo made by the attending dermatologist who first visits patient at the Afzalipour Hospital's dermatology clinic
Filling out and signing the written informed consent form by the patient
Patient's age of at least 18 years at the time of signing the informed consent
Male or nonpregnant and nonbreastfeeding female

Exclusion Criteria

Any dermatologic disorder other than vitiligo; infectious disorders; inflammatory disorders; diabetes mellitus; cardiovascular disorders; renal disorders; liver disorders; endocrinologic disorders; autoimmune disorders; any other uncompensated medical disorder
A diagnosis of segmental vitiligo made by the attending dermatologist who initially visits patient
Pregnancy or breastfeeding
History of hypersensitivity to atorvastatin
Using any type of drugs of statin group during the 8 week period immediatly before starting the trial
Using systemic immunosuppressive or immunomodulator treatments (cyclosporin A, corticosteroids) during the 4 week period immediatly before starting the trial or using azathioprine, methotrexate, mycophenolate mofetil, or janus kinase inhibitors during the 8 week period immediatly before starting the trial
Phototherapy as a treatment of vitiligo or any other disorder during the 4 week period immediatly before starting the trial
Alcohol or illicit drug use
History of dermatologic malignancy during the 5 year period immediatly before starting the trial or current dermatologic malignancy
Being involved in any other clinical trial
Noncompliant patient

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitiligo Area Scoring Index (VASI). Timepoint: At the beginning of the study (before any intervention) and 3 months after the start of study interventions. Method of measurement: VASI is defined as the product of hand units (each hand unit equals 1% body surface area involvement) times depigmentation pattern in each measured area.

Secondary Outcome Measures

Name	Time	Method
Treatment side effects. Timepoint: Throughout study period and up to 3 months after the start of the study. Method of measurement: History taking and physical exam.;Patient's satisfaction. Timepoint: Three months after the start of the study. Method of measurement: Asking patient to score her/his satisfaction on a scale of 0 to 10.;Any association between laboratory abnormalities and treatment type. Timepoint: At the beginning and at the end of the study (3 months after start of the study). Method of measurement: Blood test and measuring serum levels of variables.