Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata

NCT ID: NCT04964349

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2021-11-20

Brief Summary

Alopecia areata is believed to be an autoimmune disease. Treatment primarily relies on intralesional and topical corticosteroids. This study was conducted to evaluate Jessener Solutionas a potential therapeutic modality of Alopecia Areataversusintralesional steroid as regards the efficacy, safety, tolerability, and patients' satisfaction.

Detailed Description

Background 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.Treatment primarily relies on intralesional and topical corticosteroids.Up till now, there is nouniversally proven therapy that induces and maintains remission of Alopecia Areata in all patients.

Aims The Aim of Study is to evaluate the efficacyof Jessener solution versus intralesional steroid in treatment of Alopecia Areata.

Patients and Methods The study will include 40 patients diagnosed clinically and dermoscopically as Alopecia Areata with more than two patches of alopecia areata were included. Two treatment modalities with intralesional corticosteroid and topical Jessener Solutionas were performed in two randomly selected patches. Three sessions were done, 3 weeks apart and were followed-up for three months. Evaluation was done using Mac Donald Hull and Norris grading system , Serial photographs and dermoscopic , trichoscopic examination every month will be done and patient will be score.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intralesional cortisosteroid injection

Intralesional corticosteroid injection

Group Type: EXPERIMENTAL

Corticosteroids Acting Locally

Intervention Type: DRUG

topical application of jessener solution

jessener solution

topical jessener solution

Group Type: EXPERIMENTAL

Corticosteroids Acting Locally

Intervention Type: DRUG

topical application of jessener solution

Interventions

Corticosteroids Acting Locally

topical application of jessener solution

Intervention Type: DRUG

Other Intervention Names

topical jessener solution

Eligibility Criteria

Inclusion Criteria

• 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata.

Exclusion Criteria

• Age less than 12 yearsand more than 40years old. 2.Patient under treatment.3.Patients having another dermatological condition affecting thescalpas eczema.4.Patients with psychiatric disorders.5.Pregnant and lactating females.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Rashad Elshahid

professor of dermatology, venereology and andrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elshahid, MD

Role: STUDY_CHAIR

Alazhar faculty of medicine

Locations

Alazhar faculty of meidicine

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed pr Elshahid, MD

Role: CONTACT

ahmedandro@yahoo.com

00201006262271 ext. dermatology

Facility Contacts

ahmed Elshahid, MD

Role: primary

ahmedandro@yahoo.com

+201006262271

Other Identifiers

Ahmed Kadah

Identifier Type: OTHER

Identifier Source: secondary_id

Eman Abd-ellatif

Identifier Type: OTHER

Identifier Source: secondary_id

Alazhar faculty of medicine

Identifier Type: -

Identifier Source: org_study_id