New Topical Treatment in Patchy Alopecia Areata

ConditionAlopecia Areata

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6+

SponsorSohag University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Alopecia totalis and alopecia universalis.

Cicatricial alopecia.

Other causes of hair loss such as; endocrine or immunological disease.

Skin disease in the affected area.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: group (1) will use topical metformin 30% ointmentActive comparator 1 intervention

Group B: group (2) will use topical simvastatin 2% ointmentActive comparator 1 intervention

Group C: group (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: