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

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Pentoxifylline

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: manar I Abd elhameed, assisstent lecturer; Phone Number: 01019222552; Email: mannar.amin@med.sohag.edu.eg
• Study Contact Backup: Name: Ashraf A Abd-Ellatif, lecturer

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alopecia areata	Drug: Pentoxifylline; Combined microneedling and topicalpentoxifylline vesrus intalesional pentoxifylline in Alopecia Areata patches in the same patient

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: Soh-Med-22-07-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No