Comparison study of effect of two concentrations of intra-lesional injection of a drug in patchy hair loss of the scalp

Phase 4

Not yet recruiting

• Conditions: Alopecia areata, unspecified,

• Registration Number: CTRI/2022/11/047692

Brief Summary

1.      A detailed history will be obtained from each patient after taking the written informed consent to document the  age and sex of the patients, the presence of a positive family history (in a first–degree relative), as well as the  duration and course of the disease

2.      Clinical Examination will be done to detect associations (nail changes and any other autoimmune diseases) and to determine the type and extent of AA, which will be assessed using the Severity of Alopecia Tool (SALT) score (Annexure-II)

3.      A baseline digital camera photograph of the patch and dermoscopic parameters will be done on one representative patch of hair loss on the scalp between 12 o’clock and 3 o’clock position in clockwise direction of investigator

4.      Patient’s Proforma will be filled for all the patients included in the study.

5.      Patients will be randomly divided into 2 groups:

Group A: Intralesional injection of triamcinolone acetonide 5mg/ml will be given for 4 sessions every 3 weekly or until complete hair re-growth whichever is earlier

Group B: Intralesional injection of triamcinolone acetonide 10mg/ml will be given for 4 sessions every 3 weekly or until complete hair re-growth whichever is earlier

**6.** Monitoring of treatment response and side effects will be done in both groups every 3 weeks then at the 3 months of therapy from baseline (3 weeks after the 4th session) by an investigator through a clinical examination using Reduction in SALT Score and Re-Growth Scale (RGS), photography and dermoscopic examination with photography (dermoscopic readings will be taken in a quadrant lying between the 12 O′ clocks and at 3 O′ clock position in a clockwise direction). Side effects like pain, and epidermal and dermal atrophy will be assessed in both groups at every visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Last Update Posted: 2022-11-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 1.Patients of both sexes(males and females), aged >13 years with AA, 2.Patients having AA on the scalp with <50% involvement.
• 3.Patients who had not taken any form of treatment in the last 8 weeks.
• 4.Patients who are willing to sign the written consent form before participating in the study.

Exclusion Criteria

• 1.Patients aged <13 years 2.Patients with alopecia totalis, alopecia universalis and ophiasis.
• 3.Patients having skin diseases affecting the scalp.
• 4.Patients with active infection at the local site and with keloidal tendency.
• 5.Pregnant or lactating women or immuno-compromised patients or patients with bleeding or coagulation disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Severity Alopecia Tool (SALT) Score, 5 point semi-quantitative Re Growth Scale (RGS) and Dermoscopic Assessment	At Baseline,3 weeks, 6 weeks, 9 weeks,12 weeks

Secondary Outcome Measures

Name	Time	Method
Assess side effects with two concentrations of intra-lesional injection of triamcinolone acetonide	Every 3 weeks then at the 3 months of therapy from baseline (3weeks after the 4th session)

Trial Locations

Locations (1)

All India Institute of Medical Sciences,Bathinda; 🇮🇳 Bathinda, PUNJAB, India

All India Institute of Medical Sciences,Bathinda

🇮🇳Bathinda, PUNJAB, India

Dr Bhavnish Bansal

Principal investigator

9041944944

bansalbhavnish@gmail.com