Not Yet Recruiting

NCT Number: NCT07696585

New Topical Treatment in Patchy Alopecia Areata

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

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

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.

Primary outcomes

hair regrowth in alopecia patch

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

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).

Study contacts

Contact information is provided by the study sponsor or research team.

shereen G AbdEllah, assistant lecturer

CONTACT

[email protected]

01033835302

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Efficacy and Safety of Topical Therapy of Metformin 30%; Simvastatin 2%; and Betamethasone Valerate 0.1% in Treatment of Patients With Patchy Alopecia Areata

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting