Alopecia AreataEarly Phase 1AANCT04964349
Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
A Early Phase 1 study testing Corticosteroids Acting Locally in people with Alopecia Areata, run by Al-Azhar University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Corticosteroids Acting Locally
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2021to 20 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alazhar faculty of meidicine
Cairo
ahmed Elshahid, MD, +201006262271, ahmedandro@yahoo.com
About this study
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.
Read the 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
- Being tested
- Corticosteroids Acting Locally
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids Acting LocallyDrug
Also called topical jessener solution
topical application of jessener solution
| Study group | Role | What they receive |
|---|---|---|
| Intralesional cortisosteroid injection | Experimental | Intralesional corticosteroid injection Receives: Drug: Corticosteroids Acting Locally |
| jessener solution | Experimental | topical jessener solution Receives: Drug: Corticosteroids Acting Locally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effecacy of topical jessener solution in treatment of alopecia areata
Effecacy of topical jessener solution in treatment of alopecia areata
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start21 Apr 2021
- Primary completion21 Oct 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Rashad Elshahid, Al-Azhar University
- Investigators
- Ahmed Elshahid, MD, Study chair, Alazhar faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964349
- Sponsor's protocol ID
- Alazhar faculty of medicine
- Other IDs
- Ahmed Kadah, Eman Abd-ellatif
- Acronym
- AA
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT04964349
- Acronym / sponsor ID
- AA / Alazhar faculty of medicine
- Conditions
- Alopecia Areata
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 21 Oct 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intralesional cortisosteroid injection | Experimental | Drug: Corticosteroids Acting LocallyIntralesional corticosteroid injection |
| jessener solution | Experimental | Drug: Corticosteroids Acting Locallytopical jessener solution |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroids Acting LocallyAlso: topical jessener solutiontopical application of jessener solution | Drug | Intralesional cortisosteroid injection, jessener solution |
Primary outcome
Effecacy of topical jessener solution in treatment of alopecia areata
Time frame: 6 monthes
Effecacy of topical jessener solution in treatment of alopecia areata
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elshahid, MD study chair
Alazhar faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Corticosteroids Acting Locally in people with Alopecia Areata, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed pr Elshahid, MD (00201006262271 ext. dermatology, ahmedandro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effecacy of topical jessener solution in treatment of alopecia areata (time frame: 6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.