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| ID | Type | Description | Link |
|---|---|---|---|
| 1549/UN6.3.1/PT.00/2023 | Other Grant/Funding Number | Universitas Padjadjaran |
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Psoriasis vulgaris is a chronic inflammatory skin disease mediated by the immune system, with a complex pathogenesis that requires long-term therapy. Various inflammatory mediators that activate and are produced from the NF-κB signaling pathway play a role in the pathogenesis of psoriasis vulgaris. Topical corticosteroids are the first-line therapy for all severity levels of psoriasis vulgaris, possessing immunosuppressive, anti-inflammatory, and antimitotic effects. However, long-term use can lead to side effects such as atrophy, striae, telangiectasia, hypopigmentation, acneiform eruptions, perioral dermatitis, and hypertrichosis.
Ciplukan (Physalis angulata Linn.) contains seco-steroids and flavonoids, which exhibit anti-inflammatory, antiproliferative, and immunosuppressive effects. These effects suggest that ciplukan (Physalis angulata Linn.) could serve as an adjuvant topical therapy for psoriasis vulgaris. However, studies on the effectiveness of ciplukan (Physalis angulata Linn.) extract in topical formulations for patients with psoriasis vulgaris have not yet been conducted.
Therefore, a study is needed to assess psoriasis vulgaris lesions both subjectively using the modified PASI score and objectively using high-frequency ultrasonography and spectral Doppler ultrasonography. This would evaluate the effectiveness of ciplukan (Physalis angulata Linn.) cream as an adjuvant topical therapy for psoriasis vulgaris in reducing inflammation and accelerating clinical improvement of skin lesions in patients with psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bethametasone valerat 0,1% | Active Comparator | A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days. |
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| Ciplukan | Experimental | A minimum amount of 20 psoriasis vulgaris lesion treated with the topical formulation containing 20% ciplukan (Physalis angulata Linn.) extract, applied twice a day for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciplukan | Drug | A minimum amount of 20 psoriasis vulgaris lesion treated with the topical formulation containing 20% ciplukan (Physalis angulata Linn.) extract, applied twice a day for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Psoriasis Area and Severity Index (MPASI) | The scoring method that will be used to assess the clinical severity of each observed lesion. The minimum value is 0, and maximum value is 12. A higher scores indicate a worse outcome. | 14 days |
| Lesion thickness | High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter) | 14 days |
| Inflammation | Resistive index detected by high frequency ultrasonography will be used to assess the severity of inflammation in each observed lesion. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Oki Suwarsa, dr., Sp.D.V.E., Subsp.D.A.I., M.Kes | Faculty of Medicine Universitas Padjadjaran Bandung | Principal Investigator |
| Miranti Pangastuti, dr., Sp.D.V.E., Subsp.D.A.I | Faculty of Medicine Universitas Padjadjaran Bandung | Principal Investigator |
| Dr. Harry Galuh Nugraha, dr., Sp.Rad(K) | Faculty of Medicine Universitas Padjadjaran Bandung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasan Sadikin General Hospital | Bandung | West Java | 40161 | Indonesia |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bethametasone valerate 0,1% cream | Drug | A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days. |
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