The irritation and allergic reaction test was conducted on 12 healthy volunteers who met the inclusion, exclusion, and withdrawal or termination criteria. All volunteers had a test patch applied to the upper back for 48 hours. During this period, some discomfort at the patch site may occur. In this study, it was found that 2 volunteers requested to withdraw after 24 hours of patch application due to skin discomfort, leaving 10 healthy volunteers who completed the assessment for irritation and al
Conditions
Interventions
These are the components of the spray formula containing EOP, which are used to evaluate the safe concentration levels by assessing irritation and allergic reactions in healthy volunteers using the pa
Experimental Drug
BS, BS mixed EOP at concentration 3% to 9%, Ethyl alcohol, Ethyl Alcohol mixed EOP at concentration 3% to 9%, Ethyl Alcohol mixed methyl salicylate at concentration 2%
Sponsors
Mae Fah Luang University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers, both male and female, aged between 18-60 years. 2. Willing to cooperate and follow the research study guidelines. 3. Able to attend all scheduled appointments throughout the study period. 4. Voluntarily agree to participate in the research project after receiving a clear explanation of the research process and are willing to personally sign the consent form. They must not be participating in any other research projects simultaneously.
Exclusion criteria
Exclusion criteria: 1. Individuals with lesions or skin abnormalities on the upper back, which is the area used for the patch test. 2. Individuals with allergies, hypersensitivity, or sensitivity to cosmetics, herbs, or medications. 3. Those with a history of allergic reactions to essential oils or perfumes. 4. Those with a history of allergic reactions to adhesive patches or tapes, such as Micropore/Microfilm. 5. Individuals who are pregnant, breastfeeding, planning to become pregnant, disabled, have tattoos on their back, or are unable to avoid water contact on the test area. 6. Individuals taking medications that affect skin reactions, such as anti-histamines and immunosuppressants like corticosteroids, within two weeks prior to the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation after 48 hours of closed patch test, and then 30 minutes after removing patch test Criteria are based on ICDRG, which classify skin reactions following a closed skin patch test, either 30 minutes or 24 hours after the test patch is removed.,Allergy 24 hours after removing patch test Criteria are based on ICDRG, which classify skin reactions following a closed skin patch test, either 30 minutes or 24 hours after the test patch is removed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event include Swelling of the face, lips, tongue, and throat, Difficulty breathing or shortness of breath, Rapid or weak pulse, Dizziness or fainting, Chest tightness or pain 1. after 48 hours of closed patch test, and then 30 minutes after removing patch test and 2. 24 hours after removing patch test Observe | — |
Countries
Thailand
Contacts
Public ContactChureeporn Imphat
Mae Fah Luang University
Outcome results
None listed