Clinical trial NCT05502952: Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study
Official title: Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: measuerement of improvement of alopecia areata patches by SALT score
timeFrame: 12 month
measure: measuerement of improvement of alopecia areata patches by Trichoscopic signs
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: Lai 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.
citation: El-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.
citation: Fukumoto 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.