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

Phase 1

• Conditions: Psoriasis Vulgaris; Inflammation
• Interventions: Drug: Bethametasone valerate 0,1% cream; Drug: Ciplukan

• Registration Number: NCT06887322
• Lead Sponsor: Universitas Padjadjaran

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.

Study Timeline

• Study Start: 2025-02-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bethametasone valerat 0,1%	Bethametasone 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.
Ciplukan	Ciplukan	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hasan Sadikin General Hospital; 🇮🇩 Bandung, Jawa Barat, Indonesia