Allergy, Irritation, Sensitization
Conditions
Brief summary
A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical agent or agents have the potential to cause contact irritation or contact allergy in the skin. Allergy is only elicited in immunologically competent individuals who have become sensitized through exposure to the chemical agent at a sufficient concentration and for a sufficient duration of time.
Interventions
None listed
Sponsors
Chattem, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must not have any visible skin disease that might be confused with a skin reaction to the test trial; * Subjects must not be participating in another clinical trial at this facility or any other facility; * Subjects must be willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial; * Subjects must understand and execute and Informed Consent Form; * Subjects must be capable of understanding and following directions; * Subjects must be considered reliable; * Subjects must be aged 16 to 79 years, inclusive; * Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form.
Exclusion criteria
* Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial; * Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial; * Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products; * Subjects judged by the PI to be inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary or Cumulative Irritation Potential of the skin | 21 days | This will be measured by the evaluation of the test sites (skin)by a trained assessor with a predetermined scale for skin irritation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergic Contact Sensitization Potential | 21 days | After the repeated application period of the test material, a rest period will be employed. The test material will be applied to a naïve site and then will be evaluated by a trained assessor with a predetermined scale for skin irritation. |
Countries
United States
Outcome results
None listed