Alopecia AreataNCT05502952
Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study
A study testing Pentoxifylline in people with Alopecia Areata, run by Sohag University at 1 site in Egypt.
Trial summary
Alopecia areata (AA) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%. AA is the third most prevalent nonscarring hair loss disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2022to Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 years of both sex, with a clinical diagnosis of localised AA of two or more AA scalp patches in the same patient.
Who cannot join
- Patients who received systemic or topical treatment for A.A in the previous three months prior to the start of the study.
- Patients who are pregnant or lactating.
- Patients who have bleeding or coagulation disorders.
- Patients with autoimmune diseases, liver, or renal diseases were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Ashraf A Abd-Ellatif, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
Alopecia areata (AA) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%. AA is the third most prevalent nonscarring hair loss disease. Pentoxifylline (PTX) is a non-selective inhibitor of phosphodiesterases, which moderates the intracellular levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate by decreasing their hydrolysis and augmenting cyclic nucleotide-dependent signal transduction which leads to a wide spectrum of effects on the inflammation. PTX has anti inflammatory effects by inhibiting the pro-inflammatory cytokines (eg, IL-1, IL-6, and IL-8).Intralesional therapy has a number of advantages over topical therapy, including a faster and longer duration of action, penetration that is deeper than topical therapy, removal of the need for long-term topical medication, and improved patient compliance.The effect of microneedling for treatment of AA is supposed to stimulate the dermal papilla and stem cells by mechanical trauma and increasing the blood supply to the hair follicles.
- Conditions
- Alopecia Areata
- Being tested
- Pentoxifylline
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Combined microneedling and topicalpentoxifylline vesrus intalesional pentoxifylline in Alopecia Areata patches in the same patient
| Study group | Role | What they receive |
|---|---|---|
| Alopecia areata | Experimental | Not described Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuerement of improvement of alopecia areata patches by SALT score
The clinical response will be evaluated based on the SALT score, the following percentages of scalp hair regrowth are possible: A0 = no change or further loss, A1 = 1%-24% regrowth, A2 = 25%-49% regrowth, A3 = 50%-74% regrowth, A4 = 75%-99% regrowth, and A5 = 100% regrowth.
Measured: 12 month
measuerement of improvement of alopecia areata patches by Trichoscopic signs
Trichoscopic examination each visit to evaluate the results and record signs of improvement of the disease including (short vellus hairs and terminal hairs) and disappearance of signs of activity(exclamation marks, blackdots)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start27 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Ibrahim Abdelhameed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502952
- Sponsor's protocol ID
- Soh-Med-22-07-24
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Taieb MA, Hegazy EM, Ibrahim HM, Osman AB, Abualhamd M. Topical calcipotriol vs narrowband ultraviolet B in treatment of alopecia areata: a randomized-controlled trial. Arch Dermatol Res. 2019 Oct;311(8):629-636. doi: 10.1007/s00403-019-01943-8. Epub 2019 Jun 24.
PubMed 31236672Lai VWY, Chen G, Gin D, Sinclair R. Cyclosporine for moderate-to-severe alopecia areata: A double-blind, randomized, placebo-controlled clinical trial of efficacy and safety. J Am Acad Dermatol. 2019 Sep;81(3):694-701. doi: 10.1016/j.jaad.2019.04.053. Epub 2019 Apr 30.
PubMed 31048013El-Taweel AI, Akl EM. Intralesional pentoxifylline injection in localized alopecia areata. J Cosmet Dermatol. 2019 Apr;18(2):602-607. doi: 10.1111/jocd.12796. Epub 2018 Oct 9.
PubMed 30302901Fukumoto T, Fukumoto R, Magno E, Oka M, Nishigori C, Horita N. Treatments for alopecia areata: A systematic review and network meta-analysis. Dermatol Ther. 2021 May;34(3):e14916. doi: 10.1111/dth.14916. Epub 2021 Mar 4.
PubMed 33631058
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study
- ClinicalTrials.gov ID
- NCT05502952
- Acronym / sponsor ID
- Soh-Med-22-07-24
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 Aug 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.
Alopecia areata (AA) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%. AA is the third most prevalent nonscarring hair loss disease. Pentoxifylline (PTX) is a non-selective inhibitor of phosphodiesterases, which moderates the intracellular levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate by decreasing their hydrolysis and augmenting cyclic nucleotide-dependent signal transduction which leads to a wide spectrum of effects on the inflammation. PTX has anti inflammatory effects by inhibiting the pro-inflammatory cytokines (eg, IL-1, IL-6, and IL-8).Intralesional therapy has a number of advantages over topical therapy, including a faster and longer duration of action, penetration that is deeper than topical therapy, removal of the need for long-term topical medication, and improved patient compliance.The effect of microneedling for treatment of AA is supposed to stimulate the dermal papilla and stem cells by mechanical trauma and increasing the blood supply to the hair follicles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alopecia areata | Experimental | Drug: Pentoxifylline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 years of both sex, with a clinical diagnosis of localised AA of two or more AA scalp patches in the same patient.
Key exclusion criteria (4 listed)
- Patients who received systemic or topical treatment for A.A in the previous three months prior to the start of the study.
- Patients who are pregnant or lactating.
- Patients who have bleeding or coagulation disorders.
- Patients with autoimmune diseases, liver, or renal diseases were excluded from the study.
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 |
|---|---|---|
| PentoxifyllineCombined microneedling and topicalpentoxifylline vesrus intalesional pentoxifylline in Alopecia Areata patches in the same patient | Drug | Alopecia areata |
Primary outcome
measuerement of improvement of alopecia areata patches by SALT score
Time frame: 12 month
The clinical response will be evaluated based on the SALT score, the following percentages of scalp hair regrowth are possible: A0 = no change or further loss, A1 = 1%-24% regrowth, A2 = 25%-49% regrowth, A3 = 50%-74% regrowth, A4 = 75%-99% regrowth, and A5 = 100% regrowth.
measuerement of improvement of alopecia areata patches by Trichoscopic signs
Time frame: 12 month
Trichoscopic examination each visit to evaluate the results and record signs of improvement of the disease including (short vellus hairs and terminal hairs) and disappearance of signs of activity(exclamation marks, blackdots)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 31236672El Taieb MA, Hegazy EM, Ibrahim HM, Osman AB, Abualhamd M. Topical calcipotriol vs narrowband ultraviolet B in treatment of alopecia areata: a randomized-controlled trial. Arch Dermatol Res. 2019 Oct;311(8):629-636. doi: 10.1007/s00403-019-01943-8. Epub 2019 Jun 24.
- Background: PubMed 31048013Lai VWY, Chen G, Gin D, Sinclair R. Cyclosporine for moderate-to-severe alopecia areata: A double-blind, randomized, placebo-controlled clinical trial of efficacy and safety. J Am Acad Dermatol. 2019 Sep;81(3):694-701. doi: 10.1016/j.jaad.2019.04.053. Epub 2019 Apr 30.
- Background: PubMed 30302901El-Taweel AI, Akl EM. Intralesional pentoxifylline injection in localized alopecia areata. J Cosmet Dermatol. 2019 Apr;18(2):602-607. doi: 10.1111/jocd.12796. Epub 2018 Oct 9.
- Background: PubMed 33631058Fukumoto T, Fukumoto R, Magno E, Oka M, Nishigori C, Horita N. Treatments for alopecia areata: A systematic review and network meta-analysis. Dermatol Ther. 2021 May;34(3):e14916. doi: 10.1111/dth.14916. Epub 2021 Mar 4.
- 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.
Ashraf A Abd-Ellatif, lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline in people with Alopecia Areata, run by Sohag 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 4 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 Aug 2022. 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 manar I Abd elhameed, assisstent lecturer (01019222552, mannar.amin@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuerement of improvement of alopecia areata patches by SALT score (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502952, which also lists 4 linked publications.
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 Aug 2022.