Cream Containing Sericin and Turmeric in Psoriasis Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Sericin extract and turmeric extract cream; Drug: Triamcinolone acetonide 1% Cream

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Uncontrolled diseases
• Allergic to sericin turmeric and steroid
• Other skin diseases
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sericin extract and turmeric extract cream; Apply the sample 2 times a day for 8 weeks	Drug: Sericin extract and turmeric extract cream; Apply the sample 2 times a day for 8 weeks
Active Comparator: Triamcinolone acetonide 1% cream; Apply the sample 2 times a day for 8 weeks	Drug: Triamcinolone acetonide 1% Cream; Apply the sample 2 times a day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	8 weeks

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Antioxidants; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Turmeric extract
• Other Study ID Numbers: COA 0087/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No