Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

May 30, 2023 updated by: danyal sajjad, Combined Military Hospital Abbottabad

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Abbottabad, Khyber Pakhtunkhwa, Pakistan
        • Danyal Sajjad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A applied Clobetasol Propionate 0.05%
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.
Drug: Group A applied topical Clobetasol Propionate
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months
Active Comparator: Group B applied topical Tacrolimus 0.1%
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
Drug: Group B applied topical Tacrolimus
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital Abbottabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHAbbottabad2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia Areata

Clinical Trials on Group A applied topical Clobetasol Propionate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe