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Enrolling by Invitation

NCT Number: NCT06887322

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

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.

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Key information

Conditions

Psoriasis Vulgaris Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Modified Psoriasis Area and Severity Index (MPASI)

    Time frame: 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.

  2. Lesion thickness

    Time frame: 14 days

    High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter)

  3. Inflammation

    Time frame: 14 days

    Resistive index detected by high frequency ultrasonography will be used to assess the severity of inflammation in each observed lesion.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

The Efficacy of Topical Formulation Containing Ciplukan (Physalis Angulata Linn.) on Modified Psoriasis Area and Severity Index, Thickness, and Inflammation of Psoriasis Vulgaris Lesions

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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