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Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

NCT02061813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-26

Study results available
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Summary

The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

Conditions

  • Head Lice

Interventions

DRUG

Abametapir Lotion 0.74% w/w

applied 0.2 mL topically under occlusive condition

DRUG

Sodium Lauryl Sulfate

Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control.

DRUG

Saline 0.9%

A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control

DRUG

Placebo

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Jonathan Dosik · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-01-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061813 on ClinicalTrials.gov