PsoriasisNCT06482398
Cream Containing Sericin and Turmeric in Psoriasis Patients
A study testing Sericin extract and turmeric extract cream and Triamcinolone acetonide 1% Cream in people with Psoriasis, run by Chulalongkorn University.
Trial summary
Psoriasis lesion is divided into two parts. Half of the lesion will apply cream containing sericin and turmeric and another will apply steroid cream (control). The samples will be apply two times a day for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Sericin extract and turmeric extract cream and Triamcinolone acetonide 1% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patients with body surface area of psoriasis lesion less than 10, have psoriasis area and severity index less than 10 , and no lesion at face, hands,feet, and genital area
- No topical application on psoriasis lesion at least 2 weeks
- Willing to attend the study
Who cannot join
- Uncontrolled diseases
- Allergic to sericin turmeric and steroid
- Other skin diseases
- Pregnancy and lactation
About this study
Official title: Efficacy and Safety of Cream Containing Sericin and Turmeric in Psoriasis Patients
Psoriasis lesion is divided into two parts. Half of the lesion will apply cream containing sericin and turmeric and another will apply steroid cream (control). The samples will be apply two times a day for 8 weeks. Psoriasis area and severity index, physician global assessment, body surface area of lesion, dermatology life quality index, Itching score, adverse reaction are evaluated before, after using the samples for 4 and 8 weeks.
- Conditions
- Psoriasis
- Being tested
- Sericin extract and turmeric extract cream, Triamcinolone acetonide 1% Cream
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sericin extract and turmeric extract creamDrug
Apply the sample 2 times a day for 8 weeks
Triamcinolone acetonide 1% CreamDrug
Apply the sample 2 times a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sericin extract and turmeric extract cream | Experimental | Apply the sample 2 times a day for 8 weeks Receives: Drug: Sericin extract and turmeric extract cream |
| Triamcinolone acetonide 1% cream | Active comparator | Apply the sample 2 times a day for 8 weeks Receives: Drug: Triamcinolone acetonide 1% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index
Physician will evaluate the psoriasis lesion using Psoriasis Area and Severity Index. The score is graded 0 to 72 (low score means less severity and high score means high severity).
Measured: 8 weeks
Secondary outcomes (4)
Physician Global Assessment
Physician will evaluate the psoriasis lesion using Physician Global Assessment score (0 to 6, 0 means completely cleared, except for possible residual nonerythematous discoloration and 6 means condition worsened).
Measured: 8 weeks
Body surface area of lesion
Physician will evaluate body surface area of psoriasis lesion in percentage. (low percentage means the lesion area decrease and high percentage means the lesion area increase).
Measured: 8 weeks
Dermatology Life Quality Index
Patients will assess dermatology life quality score (0 to 30, 0 means high life quality and 30 means low life quality).
Measured: 8 weeks
Itching score
Patients will assess itching score using visual analogue scale (0 to 10, 0 means low severity and 10 means high severity).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482398
- Sponsor's protocol ID
- COA 0087/2024
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cream Containing Sericin and Turmeric in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT06482398
- Acronym / sponsor ID
- COA 0087/2024
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 1 Jul 2024 (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 lesion is divided into two parts. Half of the lesion will apply cream containing sericin and turmeric and another will apply steroid cream (control). The samples will be apply two times a day for 8 weeks. Psoriasis area and severity index, physician global assessment, body surface area of lesion, dermatology life quality index, Itching score, adverse reaction are evaluated before, after using the samples for 4 and 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sericin extract and turmeric extract cream | Experimental | Drug: Sericin extract and turmeric extract creamApply the sample 2 times a day for 8 weeks |
| Triamcinolone acetonide 1% cream | Active comparator | Drug: Triamcinolone acetonide 1% CreamApply the sample 2 times a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Patients with body surface area of psoriasis lesion less than 10, have psoriasis area and severity index less than 10 , and no lesion at face, hands,feet, and genital area
- No topical application on psoriasis lesion at least 2 weeks
- Willing to attend the study
Key exclusion criteria (4 listed)
- Uncontrolled diseases
- Allergic to sericin turmeric and steroid
- Other skin diseases
- Pregnancy and lactation
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 |
|---|---|---|
| Sericin extract and turmeric extract creamApply the sample 2 times a day for 8 weeks | Drug | Sericin extract and turmeric extract cream |
| Triamcinolone acetonide 1% CreamApply the sample 2 times a day for 8 weeks | Drug | Triamcinolone acetonide 1% cream |
Primary outcome
Psoriasis Area and Severity Index
Time frame: 8 weeks
Physician will evaluate the psoriasis lesion using Psoriasis Area and Severity Index. The score is graded 0 to 72 (low score means less severity and high score means high severity).
4 secondary outcomes
Physician Global Assessment
Time frame: 8 weeks
Body surface area of lesion
Time frame: 8 weeks
Dermatology Life Quality Index
Time frame: 8 weeks
Itching score
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sericin extract and turmeric extract cream and Triamcinolone acetonide 1% Cream in people with Psoriasis, run by Chulalongkorn University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Psoriasis Area and Severity Index (time frame: 8 weeks). 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 Jul 2024.