Healthy Volunteers
Conditions
Brief summary
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
Detailed description
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.
Interventions
A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites.
DRUGPositive Control - Sodium laurel sulfate (SLS)
Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.
OTHERPBI-100 Topical Cream, Vehicle
Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
OTHERNegative Control
A blank patch was applied daily (excluding weekends) as a negative control test site.
Sponsors
Pyramid Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The participant and evaluator are blinded to the identity of the test product (3 strengths of PBI-100), vehicle, negative control and positive control placed on each subject's forearm, upper arm or back
Intervention model description
The order of test product patch placement is randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III. * Must be willing to follow the study requirements and voluntarily give their informed consent. * Subjects must be able to read and follow study instructions in English. * Generally in good health as determined by the investigator, based on medical history interview. * Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.
Exclusion criteria
* Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study. * Sunburn within the last three weeks or use of tanning beds. * History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape. * History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria. * Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids. * History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study. * Pregnancy or mothers who are breastfeeding or planning a pregnancy. * Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritation Potential | 21 days | Irritation potential based on the Cumulative Irritation Index (CII) |
Countries
United States
Outcome results
None listed