Inflammation, Psoriasis Vulgaris
Conditions
Keywords
Physalis angulata Linn., mPASI, ultrasonography
Brief summary
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.
Detailed description
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.
Interventions
DRUGCiplukan
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.
DRUGBethametasone valerate 0,1% cream
A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days.
Sponsors
Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 60 years * Diagnosed with psoriasis vulgaris based on medical history, physical examination, and severity assessment using the PASI score
Exclusion criteria
* Pregnant or breastfeeding women. * Patients currently undergoing systemic therapy for psoriasis vulgaris. * Patients who have not discontinued systemic therapy/phototherapy for psoriasis vulgaris ≤ 30 days. * Patients with psoriasis vulgaris who have not discontinued topical therapy (other than moisturizers) ≤ 14 days. * Psoriasis vulgaris lesions located in trauma-prone areas, palms, soles, face, and skin folds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Psoriasis Area and Severity Index (MPASI) | 14 days | 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. |
| Lesion thickness | 14 days | High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter) |
| Inflammation | 14 days | Resistive index detected by high frequency ultrasonography will be used to assess the severity of inflammation in each observed lesion. |
Countries
Indonesia
Outcome results
None listed