Clinical trial NCT04882631: A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
Official title: A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pyramid Biosciences
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The order of test product patch placement is randomized.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Irritation Potential
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newtown Square
country: United States
facility: KGL Skin Study Center
state: Pennsylvania
Study officials:
affiliation: Pyramid Biosciences
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: