Clinical trial NCT06887322: The Efficacy of Topical Formulation Containing Ciplukan (Physalis Angulata Linn.) on Psoriasis Vulgaris Lesions
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Psoriasis Vulgaris
Inflammation
Keywords: Physalis angulata Linn.
mPASI
ultrasonography
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Psoriasis Area and Severity Index (MPASI)
timeFrame: 14 days
measure: Lesion thickness
timeFrame: 14 days
measure: Inflammation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: Jawa Barat
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Prof. Dr. Oki Suwarsa, dr., Sp.D.V.E., Subsp.D.A.I., M.Kes
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Miranti Pangastuti, dr., Sp.D.V.E., Subsp.D.A.I
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Dr. Harry Galuh Nugraha, dr., Sp.Rad(K)
role: PRINCIPAL_INVESTIGATOR
References: