Status:
COMPLETED
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
Lead Sponsor:
Pyramid Biosciences
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 continuou...
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 continuou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04882631
Start Date
April 12 2021
End Date
May 3 2021
Last Update
January 27 2022
Active Locations (1)
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1
KGL Skin Study Center
Newtown Square, Pennsylvania, United States, 19073