A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT04882631|
Recruitment Status : Completed
First Posted : May 12, 2021
Last Update Posted : January 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: PBI-100 Topical Cream Drug: Positive Control - Sodium laurel sulfate (SLS) Other: PBI-100 Topical Cream, Vehicle Other: Negative Control||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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|
|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 :||April 12, 2021|
|Actual Primary Completion Date :||May 3, 2021|
|Actual Study Completion Date :||May 3, 2021|
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 Name: 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.
- Irritation Potential [ Time Frame: 21 days ]Irritation potential based on the Cumulative Irritation Index (CII)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882631
|United States, Pennsylvania|
|KGL Skin Study Center|
|Newtown Square, Pennsylvania, United States, 19073|
|Study Director:||Chief Medical Officer||Pyramid Biosciences|