search
Back to results

Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Group A applied topical Clobetasol Propionate
Group B applied topical Tacrolimus
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danyal Sajjad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A applied Clobetasol Propionate 0.05%

Group B applied topical Tacrolimus 0.1%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
May 30, 2023
Sponsor
Combined Military Hospital Abbottabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05885269
Brief Title
Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata
Official Title
Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A applied Clobetasol Propionate 0.05%
Arm Type
Active Comparator
Arm Description
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.
Arm Title
Group B applied topical Tacrolimus 0.1%
Arm Type
Active Comparator
Arm Description
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
Intervention Type
Drug
Intervention Name(s)
Group A applied topical Clobetasol Propionate
Intervention Description
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months
Intervention Type
Drug
Intervention Name(s)
Group B applied topical Tacrolimus
Intervention Description
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
Primary Outcome Measure Information:
Title
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Danyal Sajjad
City
Abbottabad
State/Province
Khyber Pakhtunkhwa
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

We'll reach out to this number within 24 hrs