Alopecia AreataNCT07696585
New Topical Treatment in Patchy Alopecia Areata
A study testing topical metformin 30% ointment, Topical Simvastatin 2% ointment and Topical betamethasone valerate 0.1% ointment in people with Alopecia Areata, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- topical metformin 30% ointment, Topical Simvastatin 2% ointment and Topical betamethasone valerate 0.1% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2026to 28 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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
- Being tested
- topical metformin 30% ointment, Topical Simvastatin 2% ointment, Topical betamethasone valerate 0.1% ointment
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical metformin 30% ointmentDrug
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% ointmentDrug
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% ointmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Drug: Topical betamethasone valerate 0.1% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start28 Jun 2026 (estimated)
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherein Gamal Abdellah, Sohag University
- Investigators
- shereen G gamal, Assistant lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696585
- Sponsor's protocol ID
- Soh-Med--26-6-1MD
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07696585
- Acronym / sponsor ID
- Soh-Med--26-6-1MD
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group (1) will use topical metformin 30% ointment | Active comparator | Drug: topical metformin 30% ointmenteach 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. |
| group (2) will use topical simvastatin 2% ointment | Active comparator | Drug: Topical Simvastatin 2% ointmenteach 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 (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointment | Placebo comparator | Drug: Topical betamethasone valerate 0.1% ointmenteach 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical metformin 30% ointmenteach 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. | Drug | group (1) will use topical metformin 30% ointment |
| Topical Simvastatin 2% ointmenteach 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 | group (2) will use topical simvastatin 2% ointment |
| Topical betamethasone valerate 0.1% ointmenteach 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 | group (3)each patient (age and sex matched) will use topical betamethasone valerate 0.1% ointment |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shereen G gamal, Assistant lecturer principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing topical metformin 30% ointment, Topical Simvastatin 2% ointment and Topical betamethasone valerate 0.1% ointment in people with Alopecia Areata, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shereen G AbdEllah, assistant lecturer (01033835302, shereengamal157@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair regrowth in alopecia patch (time frame: baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.