NCT04964349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effecacy of topical jessener solution in treatment of alopecia areata

    Effecacy of topical jessener solution in treatment of alopecia areata

    6 monthes

Study Arms (2)

Intralesional cortisosteroid injection

EXPERIMENTAL

Intralesional corticosteroid injection

Drug: Corticosteroids Acting Locally

jessener solution

EXPERIMENTAL

topical jessener solution

Drug: Corticosteroids Acting Locally

Interventions

topical application of jessener solution

Also known as: topical jessener solution
Intralesional cortisosteroid injectionjessener solution

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar faculty of meidicine

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ahmed Elshahid, MD

    Alazhar faculty of medicine

    STUDY CHAIR

Central Study Contacts

Ahmed pr Elshahid, MD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: there are 2 patches of alopecia areata in the same patient one treated with intralesional injection of corticosteroid and the other one will be treated by jessenersolution
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of dermatology, venereology and andrology

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 16, 2021

Study Start

April 21, 2021

Primary Completion

October 21, 2021

Study Completion

November 20, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations