Psoriasis VulgarisPhase 1/2NCT06887322
The Efficacy of Topical Formulation Containing Ciplukan (Physalis Angulata Linn.) on Psoriasis Vulgaris Lesions
A Phase 1/2 study testing Ciplukan and Bethametasone valerate 0,1% cream in people with Psoriasis Vulgaris and Inflammation, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis Vulgaris, Inflammation
- What is being tested?
- Ciplukan and Bethametasone valerate 0,1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Feb 2025to 10 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60 years
- Diagnosed with psoriasis vulgaris based on medical history, physical examination, and severity assessment using the PASI score
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris, Inflammation
- Being tested
- Ciplukan, Bethametasone valerate 0,1% cream
- Keywords
- Physalis angulata Linn., mPASI, ultrasonography
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiplukanDrug
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% creamDrug
A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Bethametasone valerat 0,1% | Active comparator | A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days. Receives: Drug: Bethametasone valerate 0,1% cream |
| Ciplukan | Experimental | 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. Receives: Drug: Ciplukan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Psoriasis Area and Severity Index (MPASI)
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.
Measured: 14 days
Lesion thickness
High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter)
Measured: 14 days
Inflammation
Resistive index detected by high frequency ultrasonography will be used to assess the severity of inflammation in each observed lesion.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start13 Feb 2025
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Oki Suwarsa, dr., Sp.D.V.E., Subsp.D.A.I., M.Kes, Principal investigator, Faculty of Medicine Universitas Padjadjaran BandungMiranti Pangastuti, dr., Sp.D.V.E., Subsp.D.A.I, Principal investigator, Faculty of Medicine Universitas Padjadjaran BandungDr. Harry Galuh Nugraha, dr., Sp.Rad(K), Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887322
- Sponsor's protocol ID
- DV-202503.01
- Other IDs
- 1549/UN6.3.1/PT.00/2023
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887322
- Acronym / sponsor ID
- DV-202503.01
- Conditions
- Psoriasis Vulgaris, Inflammation
- Keywords
- Physalis angulata Linn., mPASI, ultrasonography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bethametasone valerat 0,1% | Active comparator | Drug: Bethametasone valerate 0,1% creamA minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days. |
| Ciplukan | Experimental | Drug: CiplukanA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 - 60 years
- Diagnosed with psoriasis vulgaris based on medical history, physical examination, and severity assessment using the PASI score
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiplukanA 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 |
| Bethametasone valerate 0,1% creamA minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days. | Drug | Bethametasone valerat 0,1% |
Primary outcome
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.
Lesion thickness
Time frame: 14 days
High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Oki Suwarsa, dr., Sp.D.V.E., Subsp.D.A.I., M.Kes principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
Miranti Pangastuti, dr., Sp.D.V.E., Subsp.D.A.I principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
Dr. Harry Galuh Nugraha, dr., Sp.Rad(K) principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ciplukan and Bethametasone valerate 0,1% cream in people with Psoriasis Vulgaris and Inflammation, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Psoriasis Area and Severity Index (MPASI) (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.