A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882631
• Other study ID #: PBI-100-101
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2021
• Est. completion date: May 3, 2021

Study information

• Verified date: January 2022
• Source: Pyramid Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PBI-100 Topical Cream
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.
• Positive Control - Sodium laurel sulfate (SLS)
Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.

Other:
• PBI-100 Topical Cream, Vehicle
Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
• Negative Control
A blank patch was applied daily (excluding weekends) as a negative control test site.

Locations

Country	Name	City	State
United States	KGL Skin Study Center	Newtown Square	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pyramid Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritation Potential	Irritation potential based on the Cumulative Irritation Index (CII)	21 days