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

NCT05502952 | Unknown

• 1 other identifier: Soh-Med-22-07-24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Alopecia areata

EXPERIMENTAL

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

Combined microneedling and topicalpentoxifylline vesrus intalesional pentoxifylline in Alopecia Areata patches in the same patient

Alopecia areata

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 31236672 BACKGROUND

• 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.

  PMID: 31048013 BACKGROUND

• 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.

  PMID: 30302901 BACKGROUND

• 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.

  PMID: 33631058 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

manar I Abd elhameed, assisstent lecturer

CONTACT

01019222552; mannar.amin@med.sohag.edu.eg

Ashraf A Abd-Ellatif, lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent lecturer at dermatology,venerology and andrology department

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 16, 2022
• Study Start: July 27, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

EG (1)