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Skin irritation and allergy testing of microemulsion from Reaun-Khi-Nok remedy and microemulsion from Piper wallichii (Miq.) Hand.-Mazz. extract by closed skin patch test in healthy volunteers (Clinical trial phase 1)

Skin irritation and allergy testing of microemulsion from Reaun-Khi-Nok remedy and microemulsion from Piper wallichii (Miq.) Hand.-Mazz. extract 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
TCTR20230701004
Enrollment
36
Registered
2023-07-01
Start date
2023-02-07
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

The patched sites were observed and graded for irritation and allergic reactions in healthy volunteers. Reuan-Khi-Nok Remedy, Piper wallichii (Miq.), Patch test, Irritation, Allergic reaction

Interventions

In this study, three microemulsion bases, namely ME1, ME2, and ME3, were utilized. The microemulsion bases were loaded with Reaun-Khi-Nok remedy and Piper wallichii (Miq.) extract at concentrations of
Experimental Drug
microemulsion from Reaun-Khi-Nok remedy and microemulsion from Piper wallichii (Miq.) Hand.-Mazz. extract

Sponsors

Department of Thai Traditional Medicine Office, Faculty of Medicine Thammasat University
Lead Sponsor
Faculty of Medicine Thammasat University ( Rangsit campus )
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Female or male aged between 18 to 60 years. 2. Volunteers must pass the screening criteria, sign informed consent before enrolling in the study and willingly cooperative for study requirement. 3. Volunteers do not participate in any other clinical trial study.

Exclusion criteria

Exclusion criteria: 1. Underlying skin disease or skin lesion on the test area or any other skin disease interfering test. 2. People with allergic to Micropore or Microfilm. 3. Has atopic dermatitis or allergic reaction to cosmetics or herbal. 4. Had positive history of hypersensitivity to RKN remedy or any ingredients in microemulsion 5. Pregnancy or breast-feeding, 6. On the test area, has tattoos, scars or burns. 7. Volunteers receive antihistamine, corticosteroids and immunosuppressive therapy in the previous 2 weeks.

Design outcomes

Primary

MeasureTime frame
Range of response At 30 minutes and 24 hours after patch removal. Grading criteria of skin reactions by Cosmetic, Toiletry, and Fragrance Association (CTFA) guidelines—

Secondary

MeasureTime frame
Z-score At 30 minutes and 24 hours after patch removal. Human primary irritation index for cosmetic products by human patch test—

Countries

Thailand

Contacts

Public ContactAtchanika Taingthum

Department of Thai Traditional Medicine Office, Faculty of Medicine Thammasat University

atchanikaploy@gmail.com0863591788

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026