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Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.
we are going to evaluate using oral immunomodulator called Roflumilast and compare its safety and efficacy to intralesional steroid injection in the treatment of Alopecia areata
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 25 participants with AA will be on Roflumilast group | Active Comparator | patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks. |
|
| 25 participants will receive intralesional steroid injection | Active Comparator | ILCs group: 5 mg/mL every 4 weeks for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16. | To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Giza | Cairo Governorate | 13114 | Egypt |
age, sex
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| intralesional steroid | Drug | intralesional injection of corticosteroid |
|
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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