Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05885269
• Other study ID #: CMHAbbottabad2021
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Group A applied topical Clobetasol Propionate
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months
• Group B applied topical Tacrolimus
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.

Locations

Country	Name	City	State
Pakistan	Danyal Sajjad	Abbottabad	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.	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)	6 months