MedPath

Treatment of Alopecia Areata

Phase 3
Conditions
Health Condition 1: L638- Other alopecia areata
Registration Number
CTRI/2024/02/062980
Lead Sponsor
Dr Rakesh Tilak raj
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.who has not received any treatment during previous 2 months before commencing of the study.

2.Patients with minimum of two patches; ranging in circumference between 3cm to 10 cm.

3.Patients with patchy patches of stable AA over the scalp

4.Patients willing to be part of the study after informed consent.

Exclusion Criteria

1.Patients treated with any other topical agent or immunosuppressive drugs.

2.Patients with scarring alopecia and scalp condition affecting the outcomes.

3.Patients who were on any allopathic or homeopathic treatment.

4.Patients with psychiatric medications and unrealistic expectations.

5.Pregnant and lactating mothers.

6.Patients with a history of keloid and hypertrophic scars.

7.Patient with any systemic disease (Cardiac, Renal, Hepatic, HIV, etc).

8.Patient with history of drug abuse.

9.Patient with collagen vascular disorder and auto-immune.

10.Patients with alopecia totalis and universalis.

11.Unwilling patients.

12.Other causes of alopecia like Androgenic alopecia, Diffuse telogen effluvium

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To assess the safety and therapeutic efficacy of 12 weeks regimen of administration of investigational products in adult Alopecia areata <br/ ><br>2.Treatment frequencyTimepoint: Baseline,4 weeks,8weeks and 12weeks
Secondary Outcome Measures
NameTimeMethod
1. Assessment of hair growth from baseline using digital photography and Dermoscopy or Trichoscopy. <br/ ><br>2.Time for regrowth <br/ ><br>3.Sustainability of hair growth response over a 12 weeks post treatment period of observation. <br/ ><br>4. Hair regrowth outcome assessment using SALT scoring.Timepoint: Post treatment observation follow up at <br/ ><br>1. 16 weeks <br/ ><br>2. 20 weeks <br/ ><br>3. 24 weeks.
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