Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study

Study Overview
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Brief Summary
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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.

Official Title
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Combined Microneedling and Topical Pentoxifylline Vesrus Intalesional Pentoxifylline in Treatment of Alopecia Areata: Intra-indiviual Comparative Study

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alopecia areata<br> | Drug: Pentoxifylline<br>* Combined microneedling and topicalpentoxifylline vesrus intalesional pentoxifylline in Alopecia Areata patches in the same patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 12 month |