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

NCT ID: NCT06887322

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2025-04-10

Brief Summary

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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

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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.

Conditions

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Psoriasis Vulgaris Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bethametasone valerate 0,1% cream

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ciplukan

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. Oki Suwarsa, dr., Sp.D.V.E., Subsp.D.A.I., M.Kes

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Miranti Pangastuti, dr., Sp.D.V.E., Subsp.D.A.I

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Dr. Harry Galuh Nugraha, dr., Sp.Rad(K)

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

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Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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1549/UN6.3.1/PT.00/2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DV-202503.01

Identifier Type: -

Identifier Source: org_study_id

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