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Assessing effectiveness of adding topical atorvastatin to vitiligo treatment

Assessing effectiveness of adding topical atorvastatin 1% ointment to topical calcineurin inhibitor treatment for nonsegmental vitiligo patients visited at Afzalipour hospital dermatology clinics

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200714048099N1
Enrollment
20
Registered
2020-08-30
Start date
2020-11-21
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo. Vitiligo

Interventions

Intervention 1: Control group patients will receive a topical placebo oint (similar in appearance to neosomal atorvastatin 1% oint) together with topical neosomal tacrolimus oint to be used twice dail

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRezvan Amiri

Kerman University of Medical Sciences

rezvanamiri1358@yahoo.com+98 34 3132 5856

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026