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Completed

NCT Number: NCT05594316

New Treatment of Alopecia Areata

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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university, Cairo, Egypt

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About this study

For each patient the following will be done :

  • History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ).
  • All patients will give a written, informed consent for induction.
  • Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55).
  • Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart.
  • serial photographs and dermoscopic examination every month will be done and patient will be score.
  • Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair.
  • histopathological examination will be done before the first session and one month after third session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trichloroacetic acid

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

Primary outcomes

  1. Mac Donald Hull and Norris grading system

    Time frame: 4 weeks after the end of treatment

    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.

  2. Scoring of texture of regrown hair

    Time frame: after each session and 4 weeks after the end of treatment

    Fine vellus hair, Intermediate hair,Normal coarse hair

  3. Scoring of pigmentation of regrown hair

    Time frame: after each session and 4 weeks after the end of treatment

    Partially pigmented, Moderately pigmented, Normally pigmented

  4. Scoring for density of hair regrowth

    Time frame: after each session and 4 weeks after the end of treatment

    No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth

  5. Scoring of overall response at the end of the study

    Time frame: after each session and 4 weeks after the end of treatment

    No response, Minimal response, Moderate response, Good response and Excellent response

  6. histopathological changes

    Time frame: after each session and 4 weeks after the end of treatment

    appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles

  7. trichoscopic parameters

    Time frame: after each session and 4 weeks after the end of treatment

    determine exclamation mark hairs, black dots, yellow dots and broken hairs

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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