Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

Sponsor
Combined Military Hospital Abbottabad (Other)
Overall Status
Completed
CT.gov ID
NCT05885269
Collaborator
(none)
70
1
2
5.9
11.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Group A applied topical Clobetasol Propionate
  • Drug: Group B applied topical Tacrolimus
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danyal Sajjad Abbottabad Khyber Pakhtunkhwa Pakistan

Sponsors and Collaborators

  • Combined Military Hospital Abbottabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
danyal sajjad, Principal investigator, Combined Military Hospital Abbottabad
ClinicalTrials.gov Identifier:
NCT05885269
Other Study ID Numbers:
  • CMHAbbottabad2021
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023