NCT06482398

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 21, 2024

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Physician Global Assessment

    8 weeks

  • Body surface area of lesion

    8 weeks

  • Dermatology Life Quality Index

    8 weeks

  • Itching score

    8 weeks

Study Arms (2)

Sericin extract and turmeric extract cream

EXPERIMENTAL

Apply the sample 2 times a day for 8 weeks

Drug: Sericin extract and turmeric extract cream

Triamcinolone acetonide 1% cream

ACTIVE COMPARATOR

Apply the sample 2 times a day for 8 weeks

Drug: Triamcinolone acetonide 1% Cream

Interventions

Apply the sample 2 times a day for 8 weeks

Sericin extract and turmeric extract cream

Apply the sample 2 times a day for 8 weeks

Triamcinolone acetonide 1% cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

SericinsTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SilkBiopolymersPolymersMacromolecular SubstancesArthropod ProteinsProteinsAmino Acids, Peptides, and ProteinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 1, 2024

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

July 31, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06