Trial Outcomes & Findings for A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies (NCT NCT02094716)

Results Overview

The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

Day 28

Results posted on

2023-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Permethrin Foam 4%/ Permethrin Foam 4% First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment
Overall Study STARTED	43	43	44
Overall Study Received Second Dose at Day 14	15	10	17
Overall Study COMPLETED	41	36	40
Overall Study NOT COMPLETED	2	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Permethrin Foam 4%/ Permethrin Foam 4% n=43 Participants First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% n=43 Participants First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam n=44 Participants First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment	Total n=130 Participants Total of all reporting groups
Age, Continuous	28.1 years STANDARD_DEVIATION 20.8 • n=5 Participants	23.4 years STANDARD_DEVIATION 18.4 • n=7 Participants	26.1 years STANDARD_DEVIATION 20.4 • n=5 Participants	25.9 years STANDARD_DEVIATION 19.8 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	69 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Intent to Treat (ITT)

The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.

Outcome measures

Outcome measures
Measure	Permethrin Foam 4%/ Permethrin Foam 4% n=43 Participants First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% n=43 Participants First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam n=44 Participants First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment	Vehicle Foam; Permethrin Foam 5% First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"	23 Participants	26 Participants	22 Participants	—

SECONDARY outcome

Timeframe: Baseline, Day 14, 28, and 42

Population: Missing data not included

The change in the total score of signs and symptoms related to the condition in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28. Scale details: The overall average presence of the individual signs and symptoms of scabies was evaluated over the entire body. Erythema, papules, pustules, crusting, scaling, excoriations, and pruritus were assessed as follows for each sign and symptom: None=0, Trace=1, Mild=2, Moderate=3, Severe=4. From these assessments, the total score of the Signs and Symptoms (from 0 to 28, higher scores mean a worse outcome) was calculated as the sum of the individual signs and symptoms scores at Baseline and Days 2, 14, 28, and 42 (if applicable).The change from baseline in the total score can range from -28 as the best reduction possible (better outcome) to +28 as the worst increase possible (worse outcome) in signs and symptoms.

Outcome measures

Outcome measures
Measure	Permethrin Foam 4%/ Permethrin Foam 4% n=10 Participants First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% n=7 Participants First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam n=7 Participants First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment	Vehicle Foam; Permethrin Foam 5% n=7 Participants First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment
Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28 Day 14 Change from Baseline	-1.1 score on a scale Standard Deviation 2.7	0.6 score on a scale Standard Deviation 2.0	-0.1 score on a scale Standard Deviation 2.5	0.6 score on a scale Standard Deviation 3.5
Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28 Day 28 Change from Prior Visit (Day 14)	-11.2 score on a scale Standard Deviation 4.5	-9.0 score on a scale Standard Deviation 5.9	-11.4 score on a scale Standard Deviation 6.7	-9.7 score on a scale Standard Deviation 7.7
Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28 Day 42 Change from Prior Visit (Day 28)	-0.5 score on a scale Standard Deviation 4.0	-2.5 score on a scale Standard Deviation 2.9	-2.4 score on a scale Standard Deviation 2.4	-3.4 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: Day 42

Population: ITT subjects who did not improve at Day 14 and received a second treatment at Day 14

Each subject was designated as "re-treatment success" at Day 42 based upon the criteria in the protocol to which he/she was enrolled. In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.

Outcome measures

Outcome measures
Measure	Permethrin Foam 4%/ Permethrin Foam 4% n=10 Participants First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% n=7 Participants First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam n=7 Participants First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment	Vehicle Foam; Permethrin Foam 5% n=7 Participants First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment
Number of Re-treated Subjects Designated as "Treatment Success"	8 Participants	4 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 28 and Day 42

The proportion of subjects designated as "treatment success" following one treatment versus two treatments. In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy. Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis. Subjects who did not improve at Day 14 were counted as failures at Day 28. Subjects who improved at Day 14 and received a second treatment in error were counted as failures at Day 28.

Outcome measures

Outcome measures
Measure	Permethrin Foam 4%/ Permethrin Foam 4% n=15 Participants First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Topical application, whole-body treatment	Permethrin Foam 5%/ Permethrin Foam 5% n=10 Participants First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Topical application, whole-body treatment	Vehicle Foam n=36 Participants First treatment with Vehicle with potential to re-treat with Permethrin Foam, if necessary. Topical application, whole-body treatment	Vehicle Foam; Permethrin Foam 5% n=42 Participants First treatment with Vehicle with second treatment of Permethrin Foam 5% at Day 14 who were also improving at Day 28. Topical application, whole-body treatment
Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose	8 Participants	4 Participants	28 Participants	30 Participants

Adverse Events

Permethrin Foam 4%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Permethrin Foam 5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Foam

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

Clinical Sciences Program Lead

Mylan Pharmaceuticals Pvt Ltd

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In the event said right to publish is exercised, the Investigator shall submit to Sponsor for review 60 days prior to any publication. In the event that Sponsor desires to take patent action, Investigator agrees to delay the publication an additional 60 days. Sponsor shall have the right to review and comment upon such publication. Notwithstanding the foregoing, no paper that incorporates Sponsor Confidential Information shall be submitted for publication without Sponsor's prior written consent.
Publication restrictions are in place

Restriction type: OTHER