New Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594316
• Other study ID #: hossam pulse
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 19, 2022

Study information

• Verified date: October 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss.

Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically, dermatoscopically and pathologically as alopecia areata Data were enrolled from department of dermatology and venereology, Al-Hussein hospital.

Description:

For each patient the following will be done :

1. History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ).

2. All patients will give a written, informed consent for induction.

3. Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55).

4. Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart.

5. serial photographs and dermoscopic examination every month will be done and patient will be score.

6. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair.

7. histopathological examination will be done before the first session and one month after third session.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 19, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.

Exclusion Criteria:

• Age less than 16 and more than 60years old. Alopecia areata of the face.

• Patient under treatment.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Trichloroacetic acid
5. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.

Locations

Country	Name	City	State
Egypt	Al-Azhar university	Cairo
Egypt	Al-Azhar university, faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mac Donald Hull and Norris grading system	regrowth of vellus hair, regrowth of sparse pigmented terminal hair, regrowth of terminal hair with patches of alopecia and regrowth of terminal hair on scalp.	4 weeks after the end of treatment
Primary	Scoring of texture of regrown hair	Fine vellus hair, Intermediate hair,Normal coarse hair	after each session and 4 weeks after the end of treatment
Primary	Scoring of pigmentation of regrown hair	Partially pigmented, Moderately pigmented, Normally pigmented	after each session and 4 weeks after the end of treatment
Primary	Scoring for density of hair regrowth	No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth	after each session and 4 weeks after the end of treatment
Primary	Scoring of overall response at the end of the study	No response, Minimal response, Moderate response, Good response and Excellent response	after each session and 4 weeks after the end of treatment
Primary	histopathological changes	appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles	after each session and 4 weeks after the end of treatment
Primary	trichoscopic parameters	determine exclamation mark hairs, black dots, yellow dots and broken hairs	after each session and 4 weeks after the end of treatment