Alopecia AreataNCT05594316
New Treatment of Alopecia Areata
A study testing Trichloroacetic acid in people with Alopecia Areata, run by Al-Azhar University at 2 sites in Egypt.
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… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Trichloroacetic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2019to 19 Oct 2022
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.
Who cannot join
- Age less than 16 and more than 60years old. Alopecia areata of the face.
- Patient under treatment.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Azhar university, faculty of medicine
Cairo
Al-Azhar university
Cairo
About this study
Official title: Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study
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.
Read the detailed description
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.
- Conditions
- Alopecia Areata
- Being tested
- Trichloroacetic acid
- Keywords
- alopecia areata AA
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichloroacetic acidDrug
- Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.
| Study group | Role | What they receive |
|---|---|---|
| single group | Other | Trichloroacetic acid Receives: Drug: Trichloroacetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after the end of treatment
Scoring of texture of regrown hair
Fine vellus hair, Intermediate hair,Normal coarse hair
Measured: after each session and 4 weeks after the end of treatment
Scoring of pigmentation of regrown hair
Partially pigmented, Moderately pigmented, Normally pigmented
Measured: after each session and 4 weeks after the end of treatment
Scoring for density of hair regrowth
No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth
Measured: after each session and 4 weeks after the end of treatment
Scoring of overall response at the end of the study
No response, Minimal response, Moderate response, Good response and Excellent response
Measured: after each session and 4 weeks after the end of treatment
histopathological changes
appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles
Measured: after each session and 4 weeks after the end of treatment
trichoscopic parameters
determine exclamation mark hairs, black dots, yellow dots and broken hairs
Measured: after each session and 4 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 May 2019
- Primary completion1 Aug 2022
- Study completion19 Oct 2022
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mamdouh Anter Esmail, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594316
- Sponsor's protocol ID
- hossam pulse
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study
- ClinicalTrials.gov ID
- NCT05594316
- Acronym / sponsor ID
- hossam pulse
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata AA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 26 Oct 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Other | Drug: Trichloroacetic acidTrichloroacetic acid |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.
Key exclusion criteria (2 listed)
- Age less than 16 and more than 60years old. Alopecia areata of the face.
- Patient under treatment.
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 |
|---|---|---|
| Trichloroacetic acid5. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart. | Drug | single group |
Primary outcome
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.
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trichloroacetic acid in people with Alopecia Areata, run by Al-Azhar University at 2 sites 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 2 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: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mac Donald Hull and Norris grading system (time frame: 4 weeks after the end of treatment). The study lists 7 primary outcomes in all. 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 26 Oct 2022.