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

Not Applicable

• Conditions: Alopecia Areata
• Interventions: Drug: Pentoxifylline

• Registration Number: NCT05502952
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-26
• Study Start: 2022-07-27
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-14
• Last Update Submitted: 2022-08-14
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alopecia areata	Pentoxifylline	-

Primary Outcome Measures

Name	Time	Method
measuerement of improvement of alopecia areata patches by Trichoscopic signs	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)
measuerement of improvement of alopecia areata patches by SALT score	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.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt