The Efficacy of Topical Formulation Containing Ciplukan (Physalis Angulata Linn.) on Psoriasis Vulgaris Lesions

Universitas Padjadjaran

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Inflammation; Psoriasis Vulgaris

Treatments: Drug: Bethametasone valerate 0,1% cream; Drug: Ciplukan

Study type: Interventional

Funder types: Other

Identifiers

NCT06887322

1549/UN6.3.1/PT.00/2023 (Other Grant/Funding Number)

DV-202503.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Bethametasone valerat 0,1%

Active Comparator group

Description:

A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days.

Treatment:

Drug: Bethametasone valerate 0,1% cream

Ciplukan

Experimental group

Description:

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.

Treatment:

Drug: Ciplukan