Microemulsion-Based Delivery of Sahasthara Ethanolic Extract: Optimized Formulation, Stability, and Clinical Safety for Topical Anti-Inflammatory Therapy

Skin irritation and allergy testing of Microemultion from Sahasthara extract for knee osteoarthritis by closed skin patch test in healthy volunteers (Clinical trial phase 1)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260420002

Enrollment

Registered

2026-04-20

Start date

2020-12-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritation and Allergy conditions Irritation, Allergy, Volunteer

Interventions

The test materials were applied to Patch Test Chambers. Each patch was affixed securely to the upper back of the volunteer for 48 hours, using a protective overlay to maintain consistent application.

Experimental Drug

SHT-ME

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. known hypersensitivity to any component of SHTe-ME 2. pregnancy or lactation 3. existing skin conditions at the test area or other dermatological disorders that could interfere with the study 4. a history of atopic dermatitis or hypersensitivity to cosmetics, herbal products, or pharmaceuticals 5. known allergy to Micropore or Microfilm 6. recent use (within the past 2 weeks) of antihistamines, corticosteroids, or immunosuppressive agents.

Exclusion criteria

Exclusion criteria: Participants experiencing severe adverse events during the study, including anaphylaxis, severe asthma, nausea, or vomiting, were withdrawn from the trial.

Design outcomes

Primary

Measure	Time frame
Skin irritation and allergic testing 72 h 1. International Contact Dermatitis Research Group (ICDRG) classification 2. The Cosmetic, Toiletry, and Fragrance Association (CTFA) 3. The Human Primary Irritation Index (HPII)	—

Secondary

Measure	Time frame
Adverse Reaction 72 h Volunteer questionnaire and evaluation by dermatologists	—

Countries

Thailand

Contacts

Public ContactNinnart Intharit

Thammasat University

ninnarti@nu.ac.th0956408744

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026