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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05594316
Other study ID # hossam pulse
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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