Trial Outcomes & Findings for Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion (NCT NCT02061813)

NCT ID: NCT02061813

Last Updated: 2021-07-26

Results Overview

The evaluation of irritation is based on Modified Berger procedure and is accepted as standard methodology for assessment of cumulative irritation potential. The assessment of all patch sites for irritation symptoms will be visually assessed by a trained evaluator using the numerical equivalents (0-7) where 0 is the least irritation potential and 7 is the maximum irritation potential. The scoring will be done on daily basis from baseline through Day 21 visit. The final reported outcome is a mean of the scores over 21 days.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2021-07-26

Participant Flow

Unit of analysis: Skin sites

Participant milestones

Measure	All Randomized Subjects All Randomized Subjects included all subjects who were enrolled into the study. All subjects had the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.
Overall Study STARTED	40 160
Overall Study Abametapir Lotion	40 40
Overall Study Vehicle Lotion	40 40
Overall Study Saline 0.9%	40 40
Overall Study SLS 0.2%	40 40
Overall Study COMPLETED	37 148
Overall Study NOT COMPLETED	3 12

Reasons for withdrawal

Measure	All Randomized Subjects All Randomized Subjects included all subjects who were enrolled into the study. All subjects had the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	2

Baseline Characteristics

Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

Baseline characteristics by cohort

Measure	All Randomized Subjects n=40 Participants All Randomized Subjects included all subjects who were enrolled into the study. All subjects had the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.
Age, Customized	46.95 years STANDARD_DEVIATION 14.98 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Type 1	1 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Type 2	15 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Type 3	11 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Type 4	12 Participants n=5 Participants
Fitzpatrick Skin Type Fitzpatrick Type 5	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: All Randomized Subjects

The evaluation of irritation is based on Modified Berger procedure and is accepted as standard methodology for assessment of cumulative irritation potential. The assessment of all patch sites for irritation symptoms will be visually assessed by a trained evaluator using the numerical equivalents (0-7) where 0 is the least irritation potential and 7 is the maximum irritation potential. The scoring will be done on daily basis from baseline through Day 21 visit. The final reported outcome is a mean of the scores over 21 days.

Outcome measures

Measure	Abametapir Lotion Group n=40 Skin Sites All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	Vehicle Lotion n=40 Skin Sites All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	Saline 0.9% n=40 Skin Sites All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	Sodium Lauryl Sulphate (SLS) n=40 Skin Sites All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans.	1.10 score on a scale Standard Deviation 3.11	0.70 score on a scale Standard Deviation 2.89	1.10 score on a scale Standard Deviation 6.48	49.15 score on a scale Standard Deviation 8.87

Adverse Events

All Randomized Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Srinivas Sidgiddi

Dr. Reddy's Laboratories Inc.

Phone: 9084585362

Email: srinivassidgiddi@drreddys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place