MedPath

Cumulative Irritation Test

Phase 1
Completed
Conditions
Tinea Pedis
Interventions
Drug: AN2718
Other: Sodium Lauryl Sulfate
Registration Number
NCT00781664
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed Description

Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
Inclusion Criteria

Subjects must meet all of the following criteria for inclusion in the study.

  1. Healthy volunteers of either sex, at least 18 years of age or older.
  2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
  3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
  4. Willingness to follow the study procedures and complete the study.
  5. Written informed consent obtained.
Read More
Exclusion Criteria
  1. Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
  2. Chronic asthma will be excluded.
  3. Pregnant or nursing mothers.
  4. A history of sensitivity to any component of any of the formulations.
  5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BAN2718AN2718 Cream SF, 0.3%
EAN2718AN2718 Gel, 1.5%
HAN2718AN2718 Gel, 7.5%
ISodium Lauryl SulfateSodium Lauryl Sulfate, 0.5%
CAN2718AN2718 Cream SF, 1%
GAN2718AN2718 Gel, 5%
AAN2718AN2718 Cream SF Vehicle
DAN2718AN2718 Gel Vehicle
FAN2718AN2718 Gel, 2.5%
Primary Outcome Measures
NameTimeMethod
Irritation Score (5-point scale)Daily for 21 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Education and Research Foundation, Inc.

🇺🇸

Lynchburg, Virginia, United States

© Copyright 2025. All Rights Reserved by MedPath