Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
Study Overview
Brief Summary
Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients age 20 to 50 years
- •Both male and female
- •Duration of illness less than 2 months
- •those who never received any treatment before
Exclusion Criteria
- •Patients having duration of alopecia greater than 2 months
- •Atypical alopecia areata i.e., Alopecia universalis etc
- •Hypersensitivity history to topical corticosteroids or tacrolimus
- •patients taking any systemic immune suppression
- •pregnancy/lactation
Arms & Interventions
Group B applied topical Tacrolimus 0.1%
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
Intervention: Group B applied topical Tacrolimus (Drug)
Group A applied Clobetasol Propionate 0.05%
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.
Intervention: Group A applied topical Clobetasol Propionate (Drug)
Outcomes
Primary Outcomes
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
Time Frame: 6 months
The degree of response was assessed on the basis of hair regrowth as excellent (\>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth)
Secondary Outcomes
No secondary outcomes reported
Investigators
danyal sajjad
Principal investigator
Combined Military Hospital Abbottabad