Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata.

NCT06087796 | Unknown Phase 1

• 1 other identifier: Topicals in Alopecia areata
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of topical pentoxifylline 2% gel and topical metformin 10% gel versus topical betamethasone valerate 0.1% cream, in treatment of patchy alopecia areata.

Conditions

Alopecia Areata

Keywords

metformin; pentoxiphylline; betamethasone valerate; alopecia areata

Outcome Measures

Primary Outcomes (1)

• Evaluation of hair regrowth in alopecia areata using SALT score.

  The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40% (0.40), right side = 18% (0.18), left side = 18% (0.18) and the posterior aspect = 24% (0.24). Percentage of hair loss in any of the four areas is multiplied by the percentage of the scalp covered in that area. The SALT score is the sum of the percentage of hair loss in all the areas mentioned above.

  8 months

Study Arms (3)

Topical betamethasone

ACTIVE COMPARATOR

Group A will include 20 patients and will receive topical betamethasone valerate 0.1% cream. Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.

Drug: Betamethasone Valerate 0.1% Cream

Topical pentoxifylline

EXPERIMENTAL

Group B will include 20 patients who will receive topical pentoxifylline 2% gel. Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.

Drug: Pentoxifylline

Topical metformin

EXPERIMENTAL

Group C will include 20 patients who will receive topical metformin 10% gel. Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.

Drug: Metformin

Interventions

Betamethasone Valerate 0.1% Cream DRUG

Topical treatment modality for alopecia areata.

Also known as: Topical betamethasone

Topical betamethasone

Pentoxifylline DRUG

Topical treatment modality for alopecia areata.

Also known as: topical pentoxifylline

Topical pentoxifylline

Metformin DRUG

Topical treatment modality for alopecia areata.

Also known as: Topical metformin

Topical metformin

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A clinical diagnosis of patchy alopecia areata of scalp involving \< 50% of the total scalp confirmed by dermoscopy of both males and females.
• patients age between 6 and 60 years old.

You may not qualify if:

• Alopecia totalis and alopecia universalis.
• Cicatricial alopecia.
• Other causes of hair loss such as; endocrine or immunological disease.
• Skin disease in the affected area.
• Hypersensitivity or allergy to any of the treatment products used.
• Patient using treatment (topical or systemic) for alopecia areata in the last 2 months.
• Systemic administration of any of the three test drugs (pentoxifylline, metformin and steroids).
• Pregnant and lactating females.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (11)

• Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.

  PMID: 24202232 BACKGROUND

• Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015 Feb;14(2):81-9. doi: 10.1016/j.autrev.2014.10.014. Epub 2014 Oct 12.

  PMID: 25315746 BACKGROUND

• Juarez-Rendon KJ, Rivera Sanchez G, Reyes-Lopez MA, Garcia-Ortiz JE, Bocanegra-Garcia V, Guardiola-Avila I, Altamirano-Garcia ML. Alopecia Areata. Current situation and perspectives. Arch Argent Pediatr. 2017 Dec 1;115(6):e404-e411. doi: 10.5546/aap.2017.eng.e404. English, Spanish.

  PMID: 29087123 BACKGROUND

• Karimkhani C, Boyers LN, Prescott L, Welch V, Delamere FM, Nasser M, Zaveri A, Hay RJ, Vos T, Murray CJ, Margolis DJ, Hilton J, MacLehose H, Williams HC, Dellavalle RP. Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews. JAMA Dermatol. 2014 Sep;150(9):945-51. doi: 10.1001/jamadermatol.2014.709.

  PMID: 24807687 BACKGROUND

• Zargari O. Pentoxifylline: a drug with wide spectrum applications in dermatology. Dermatol Online J. 2008 Nov 15;14(11):2.

  PMID: 19094840 BACKGROUND

• Speirs C, Williams JJL, Riches K, Salt IP, Palmer TM. Linking energy sensing to suppression of JAK-STAT signalling: A potential route for repurposing AMPK activators? Pharmacol Res. 2018 Feb;128:88-100. doi: 10.1016/j.phrs.2017.10.001. Epub 2017 Oct 13.

  PMID: 29037480 BACKGROUND

• Speiser JJ, Mondo D, Mehta V, Marcial SA, Kini A, Hutchens KA. Regulatory T-cells in alopecia areata. J Cutan Pathol. 2019 Sep;46(9):653-658. doi: 10.1111/cup.13479. Epub 2019 May 15.

  PMID: 30989699 BACKGROUND

• Araoye EF, Thomas JAL, Aguh CU. Hair regrowth in 2 patients with recalcitrant central centrifugal cicatricial alopecia after use of topical metformin. JAAD Case Rep. 2020 Jan 22;6(2):106-108. doi: 10.1016/j.jdcr.2019.12.008. eCollection 2020 Feb. No abstract available.

  PMID: 32016152 BACKGROUND

• Tawfeek HM, Abou-Taleb DAE, Badary DM, Ibrahim M, Abdellatif AAH. Pharmaceutical, clinical, and immunohistochemical studies of metformin hydrochloride topical hydrogel for wound healing application. Arch Dermatol Res. 2020 Mar;312(2):113-121. doi: 10.1007/s00403-019-01982-1. Epub 2019 Oct 16.

  PMID: 31620870 BACKGROUND

• Jha AK, Udayan UK, Roy PK, Amar AKJ, Chaudhary RKP. Dermoscopy of alopecia areata-a retrospective analysis. Dermatol Pract Concept. 2017 Apr 30;7(2):53-57. doi: 10.5826/dpc.0702a12. eCollection 2017 Apr.

  PMID: 28515996 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 RESULT

MeSH Terms

Conditions

Alopecia Areata

Interventions

Betamethasone Valerate; Betamethasone; Pentoxifylline; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Nada K. Mostafa, bachelor

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa A. Moubasher, bachelor

CONTACT

+201227370734; alaaeldeen.moubasher@med.aun.eg

Alaa M. Ghazally, MD

CONTACT

+201007224787; alaa_ghazally@aun.med.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 18, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)