New Topical Treatment in Patchy Alopecia Areata
Efficacy and Safety of Topical Therapy of Metformin 30%; Simvastatin 2%; and Betamethasone Valerate 0.1% in Treatment of Patients With 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: shereen G AbdEllah, assistant lecturer
- Phone Number: 01033835302
- Email: shereengamal157@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group (1) will use topical metformin 30% ointment
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.
|
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.
|
|
Active Comparator: group (2) will use topical simvastatin 2% ointment
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 |
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 |
|
Placebo Comparator: group (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointment
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: shereen G gamal, Assistant lecturer, Sohag University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Alopecia
- Hypotrichosis
- Hair Diseases
- Skin and Connective Tissue Diseases
- Alopecia Areata
- Organic Chemicals
- Pharmaceutical Preparations
- Dosage Forms
- Hydrocarbons
- Hydrocarbons, Cyclic
- Naphthalenes
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Biguanides
- Guanidines
- Amidines
- Betamethasone
- Lovastatin
- Betamethasone Valerate
- Metformin
- Simvastatin
- Ointments
Other Study ID Numbers
- Soh-Med--26-6-1MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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