New Topical Treatment in Patchy Alopecia Areata

NCT07696585 | Not Yet Recruiting

• 1 other identifier: Soh-Med--26-6-1MD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alopecia areata (AA) is a chronic immune disease characterized by non-scarring hair loss of the scalp or other hair-bearing areas Patients with AA frequently report high levels of dissatisfaction with commonly used treatment options due to ineffectiveness and adverse effects. Therefore, a substantial unmet need exists for safe and effective treatments for patients with AA. Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. The main mechanism of action for metformin involves enhancing insulin sensitivity, reducing gluconeogenesis, and promoting the absorption of glucose in muscles. In addition to its hypoglycemic effect, metformin can serve as an anti-inflammatory agent.Statins are hydroxy-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, commonly used for their lipid-lowering properties to lower cholesterol levels and treat cardiovascular disease, but they also possess powerful anti-inflammatory and immunomodulatory effects. Simvastatin belongs to the statin family. Lately, Simvastatin is utilized in treatment of several dermatological diseases. It showed efficacy in treatment of psoriasis , vitiligo, xanthomas, atopic dermatitis and acne vulgaris. This study is considered as the first study to assess and compare the efficacy and safety of of topical therapy of metformin 30 %; simvastatin 2 %; and betamethasone valerate 0.1 % in treatment of patients with patchy alopecia areata.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• hair regrowth in alopecia patch

  hair regrowth will be evaluated using the severity of alopecia tool (SALT) score. the SALT score ranges from 0 to 100, with lower scores indicating less scalp hair loss ( better outcome).

  baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion

Study Arms (3)

group (1) will use topical metformin 30% ointment

ACTIVE COMPARATOR

each patient will use topical metformin 30% ointment twice daily for 12 weeks. Preparation of metformin 30% ointment: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. then grinding the powder with a suitable wetting agent (e.g., propylene glycol) to form a smooth paste, followed by incorporation into an appropriate ointment base using geometric dilution until uniform distribution is achieved. The final product will be packed in an airtight container and stored at room temperatur.

Drug: topical metformin 30% ointment

group (2) will use topical simvastatin 2% ointment

ACTIVE COMPARATOR

each patient (age, sex matched) will use topical simvastatin 2% ointment twice daily for 12 weeks. Preparation of simvastatin 2% ointment: Simvastatin powder will be levigated or solubilized in propylene glycol prior to incorporation into a white soft paraffin, using geometric dilution to ensure uniform distribution. The final formulation will be stored in a light-resistant container at room temperature

Drug: Topical Simvastatin 2% ointment

group (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointment

PLACEBO COMPARATOR

each patient (age, sex matched) will use topical betamethasone valerate 0.1% ointment twice daily for 12 weeks. oManufactured by Egyptian international pharmaceutical industries co. E.I.P.I.C.O. and will be purchased from local pharmacy, Sohag, Egypt.

Drug: Topical betamethasone valerate 0.1% ointment

Interventions

topical metformin 30% ointment DRUG

each patient will use topical metformin 30% ointment twice daily for 12 weeks. oPreparation of metformin 30% ointment: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. then grinding the powder with a suitable wetting agent (e.g., propylene glycol) to form a smooth paste, followed by incorporation into an appropriate ointment base using geometric dilution until uniform distribution is achieved. The final product will be packed in an airtight container and stored at room temperature.

group (1) will use topical metformin 30% ointment

Topical Simvastatin 2% ointment DRUG

each patient (age, sex matched) will use topical simvastatin 2% ointment twice daily for 12 weeks. Preparation of simvastatin 2% ointment: Simvastatin powder will be levigated or solubilized in propylene glycol prior to incorporation into a white soft paraffin, using geometric dilution to ensure uniform distribution. The final formulation will be stored in a light-resistant container at room temperature

group (2) will use topical simvastatin 2% ointment

Topical betamethasone valerate 0.1% ointment DRUG

each patient (age, sex matched) will use topical betamethasone valerate 0.1% ointment twice daily for 12 weeks. oManufactured by Egyptian international pharmaceutical industries co. E.I.P.I.C.O. and will be purchased from local pharmacy, Sohag, Egypt.

group (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointment

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients of both sexes aged ≥ 6 years (children and adults), having clinical and trichscopic finding of alopecia areata (involving \< 50% of the total scalp) and did not receive any topical or systemic treatment in the last 3 months for alopecia areata.

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 to any of the treatment products used.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Alopecia Areata

Interventions

Metformin; Ointments; Simvastatin; Betamethasone Valerate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• shereen G gamal, Assistant lecturer

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shereen G AbdEllah, assistant lecturer

CONTACT

01033835302; shereengamal157@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of dermatology

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 10, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): December 28, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share