Clincosm LogoSign in Get a demo

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

Sponsor
Pyramid Biosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04882631
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
21
Actual Duration (Days)
43.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PBI-100 Topical Cream
  • Drug: Positive Control - Sodium laurel sulfate (SLS)
  • Other: PBI-100 Topical Cream, Vehicle
  • Other: Negative Control
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The order of test product patch placement is randomized.The order of test product patch placement is randomized.
Masking:
None (Open Label)
Masking Description:
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
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 12, 2021
Actual Primary Completion Date :
May 3, 2021
Actual Study Completion Date :
May 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

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.
Other Names:
  • SLS

    • 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.

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

    Outcome Measures

    Primary Outcome Measures

    1. Irritation Potential [21 days]

      Irritation potential based on the Cumulative Irritation Index (CII)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KGL Skin Study Center Newtown Square Pennsylvania United States 19073

    Sponsors and Collaborators

    • Pyramid Biosciences

    Investigators

    • Study Director: Chief Medical Officer, Pyramid Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pyramid Biosciences
    ClinicalTrials.gov Identifier:
    NCT04882631
    Other Study ID Numbers:
    • PBI-100-101
    First Posted:
    May 12, 2021
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 27, 2022