Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

NCT05885269 | Completed Phase 1

• 1 other identifier: CMHAbbottabad2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A applied Clobetasol Propionate 0.05%

ACTIVE COMPARATOR

Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.

Drug: Group A applied topical Clobetasol Propionate

Group B applied topical Tacrolimus 0.1%

ACTIVE COMPARATOR

Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.

Drug: Group B applied topical Tacrolimus

Interventions

Group A applied topical Clobetasol Propionate DRUG

Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months

Group A applied Clobetasol Propionate 0.05%

Group B applied topical Tacrolimus DRUG

Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.

Group B applied topical Tacrolimus 0.1%

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age 20 to 50 years
• Both male and female
• Duration of illness less than 2 months
• those who never received any treatment before

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Danyal Sajjad

Abbottabad, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 1, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)