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

NCT04882631 | Completed Phase 1 FDA Drug

• 1 other identifier: PBI-100-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Irritation Potential

  Irritation potential based on the Cumulative Irritation Index (CII)

  21 days

Study Arms (1)

Cumulative Irritation Test

EXPERIMENTAL

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.

Drug: PBI-100 Topical Cream; Drug: Positive Control - Sodium laurel sulfate (SLS); Other: PBI-100 Topical Cream, Vehicle; Other: Negative Control

Interventions

PBI-100 Topical Cream 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.

Cumulative Irritation Test

Positive Control - Sodium laurel sulfate (SLS) DRUG

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

Also known as: SLS

Cumulative Irritation Test

PBI-100 Topical Cream, Vehicle OTHER

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

Cumulative Irritation Test

Negative Control OTHER

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

Cumulative Irritation Test

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pyramid Biosciences: lead

Study Sites (1)

KGL Skin Study Center

Newtown Square, Pennsylvania, 19073, United States

Location

Study Officials

• Chief Medical Officer

  Pyramid Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The order of test product patch placement is randomized.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: April 12, 2021
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)