Alopecia AreataNCT06088147
Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata
A study testing Methotrexate and Triamcinolone Acetonide in people with Alopecia Areata, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Alopecia areata is the second most common cause of hair loss following androgenic alopecia. It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Methotrexate and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2023to Jun 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age groups: > 12 years old.
- Sex: both sexes.
- Co-operative Patients.
- Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.
Who cannot join
- Patients <12 years.
- Pregnant and lactating women.
- Patients with any underlying Systemic disorders.
- Patients with HBV or HCV.
- Patient with active infection of T.B.
- Patients with bone marrow suppression (leukopenia, thrombocytopenia)
- Patients who had received any other modalities of treatment in last 3-6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata
Alopecia areata is the second most common cause of hair loss following androgenic alopecia.
It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.
Read more
Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.
Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.
- Conditions
- Alopecia Areata
- Being tested
- Methotrexate, Triamcinolone Acetonide
- Keywords
- Alopecia areata, Methotrexate, Triamcinolone, microneedling
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
A standard derma pen 12 pins with of 0,5 mm depth was used, dermapen as a tool of infusion of our treatments works in a few ways to target hair loss, firstly by breaking down the scar tissue that covers or compromises the hair follicles which are not growing, stimulating new hair growth and also by enhancing infusion of mesotherapy ingredients to increase hair follicle size and therefore hair volume ,here we will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2
Triamcinolone AcetonideDrug
A standard derma pen 12 pins with of 0,5 mm depth was used, will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution
| Study group | Role | What they receive |
|---|---|---|
| Group 1= Methotrexate | Active comparator | After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern. Receives: Drug: Methotrexate |
| Group2=Triamcinilone | Experimental | we will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (> 75% increase in% SALT score).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athar Fathy Abodief, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088147
- Sponsor's protocol ID
- MSc/AZ.AST/DVA021/6/215/1/2023
- Status last verified
- Nov 2023
- First submitted
- 25 Aug 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata
- ClinicalTrials.gov ID
- NCT06088147
- Acronym / sponsor ID
- MSc/AZ.AST/DVA021/6/215/1/2023
- Conditions
- Alopecia Areata
- Keywords
- Alopecia areata, Methotrexate, Triamcinolone, microneedling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Oct 2023 (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 the second most common cause of hair loss following androgenic alopecia.
It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.
Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.
Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1= Methotrexate | Active comparator | Drug: MethotrexateAfter microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern. |
| Group2=Triamcinilone | Experimental | Drug: Triamcinolone Acetonidewe will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age groups: > 12 years old.
- Sex: both sexes.
- Co-operative Patients.
- Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.
Key exclusion criteria (7 listed)
- Patients <12 years.
- Pregnant and lactating women.
- Patients with any underlying Systemic disorders.
- Patients with HBV or HCV.
- Patient with active infection of T.B.
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 |
|---|---|---|
| MethotrexateA standard derma pen 12 pins with of 0,5 mm depth was used, dermapen as a tool of infusion of our treatments works in a few ways to target hair loss, firstly by breaking down the scar tissue that covers or compromises the hair follicles which are not growing, stimulating new hair growth and also by enhancing infusion of mesotherapy ingredients to increase hair follicle size and therefore hair volume ,here we will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 | Drug | Group 1= Methotrexate |
| Triamcinolone AcetonideA standard derma pen 12 pins with of 0,5 mm depth was used, will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution | Drug | Group2=Triamcinilone |
Primary outcome
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
Time frame: 6 months
Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (> 75% increase in% SALT score).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate and Triamcinolone Acetonide 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 4 inclusion and 7 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 13 Nov 2023. 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.
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 Athar Fathy Abodief (01030055632, atharfathy.2344@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata. (time frame: 6 months). 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 13 Nov 2023.