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Clinical Trials/CTRI/2024/07/070467
CTRI/2024/07/070467Not yet recruitingPhase 4

A Comparative Study To Evaluate The Efficacy Of Intralesional Injections Of Triamcinolone Acetonide Versus Vitamin D3 In The Treatment Of Alopecia Areata

Medha Mishra1 site in 1 country72 target enrollmentStarted: August 1, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Improvement of SALT Scoring and Digital Photography.

Study Overview

Brief Summary

TITLE - A Comparative study to evaluate the efficacy of Intralesional injections of Triamcinolone acetonide versus Vitamin D3 in the treatment of Alopecia areata

BACKGROUND-

Alopecia areata is an autoimmune condition .Immune system mistakenly attacks hair follicles that leads to patches of non scarring hair loss. Exact cause of alopecia areata is not known and believed to involve a combination of genetic, environmental, and immunological factors.  Intralesional Cortiocosteroid affect local cytokine expression leading to gradual decrease in type 1 and 2 cytokines in parallel with clinical improvement suggesting direct suppression of local immune response. Vitamin D receptors (VDRs) highly expressed in keratinocytes of human hair follicles and absence of expression of VDRs associated with reduced hair follicle growth and epidermal differentiation.

MATERIAL AND METHODS - The study was a prospective, randomized, open-labeled investigation conducted over 18 months. It took place at the Department of Pharmacology, in collaboration with the Department of Dermatology, at Era’s Lucknow Medical College and Hospital in Lucknow. The research focused on patients presenting to the Dermatology outpatient department with a clinical diagnosis of alopecia areata. The sample size consisted of 72 patients, divided equally into two groups of 36 each.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Non-scarring, patchy hair loss over the scalp.
  • Patients who have not received any treatment for Alopecia areata in past 4 weeks.

Exclusion Criteria

  • Individuals under 18 years of age.
  • Women who are pregnant and lactating.
  • Patients with local site skin infection.
  • Patients on Immunosuppresants.
  • Patients with underlying malignancies.
  • Patients taking Vitamin D supplements in last 6 months.

Outcomes

Primary Outcomes

Improvement of SALT Scoring and Digital Photography.

Time Frame: 3rd week 6th week 9th week and 12th week

Secondary Outcomes

  • Adverse drug reaction(3, 6, 9 and 12th week)

Investigators

Sponsor
Medha Mishra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Medha Mishra

Eras Lucknow Medical College and Hospital

Study Sites (1)

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