Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

NCT ID: NCT05885269

Last Updated: 2023-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A applied Clobetasol Propionate 0.05%

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

Group Type ACTIVE_COMPARATOR

Group A applied topical Clobetasol Propionate

Intervention Type DRUG

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

Group B applied topical Tacrolimus 0.1%

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

Group Type ACTIVE_COMPARATOR

Group B applied topical Tacrolimus

Intervention Type DRUG

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

Interventions

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Group A applied topical Clobetasol Propionate

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

Intervention Type DRUG

Group B applied topical Tacrolimus

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital Abbottabad

OTHER

Sponsor Role lead

Responsible Party

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danyal sajjad

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danyal Sajjad

Abbottabad, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CMHAbbottabad2021

Identifier Type: -

Identifier Source: org_study_id

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