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

NCT ID: NCT04882631

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2021-05-03

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cumulative Irritation Test

Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.

Group Type: EXPERIMENTAL

PBI-100 Topical Cream

Intervention Type: DRUG

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)

Intervention Type: DRUG

Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.

PBI-100 Topical Cream, Vehicle

Intervention Type: OTHER

Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.

Negative Control

Intervention Type: OTHER

A blank patch was applied daily (excluding weekends) as a negative control test site.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

PBI-100 Topical Cream, Vehicle

Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.

Intervention Type: OTHER

Negative Control

A blank patch was applied daily (excluding weekends) as a negative control test site.

Intervention Type: OTHER

Other Intervention Names

SLS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pyramid Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Pyramid Biosciences

Locations

KGL Skin Study Center

Newtown Square, Pennsylvania, United States

Countries

United States

Other Identifiers

PBI-100-101

Identifier Type: -

Identifier Source: org_study_id