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

March 26, 2025 updated by: Universitas Padjadjaran

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40161
        • Hasan Sadikin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bethametasone valerat 0,1%
A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days.
Drug: 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.
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days
Lesion thickness
Time Frame: 14 days
High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV-202503.01
  • 1549/UN6.3.1/PT.00/2023 (Other Grant/Funding Number: Universitas Padjadjaran)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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