Cumulative Irritation Test

NCT00781664 | Completed Phase 1

• 1 other identifier: AN2718-TP-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• Irritation Score (5-point scale)

  Daily for 21 days

Study Arms (9)

A

EXPERIMENTAL

AN2718 Cream SF Vehicle

Other: AN2718

B

EXPERIMENTAL

AN2718 Cream SF, 0.3%

Drug: AN2718

C

EXPERIMENTAL

AN2718 Cream SF, 1%

Drug: AN2718

D

EXPERIMENTAL

AN2718 Gel Vehicle

Other: AN2718

E

EXPERIMENTAL

AN2718 Gel, 1.5%

Drug: AN2718

F

EXPERIMENTAL

AN2718 Gel, 2.5%

Drug: AN2718

G

EXPERIMENTAL

AN2718 Gel, 5%

Drug: AN2718

H

EXPERIMENTAL

AN2718 Gel, 7.5%

Drug: AN2718

I

ACTIVE COMPARATOR

Sodium Lauryl Sulfate, 0.5%

Other: Sodium Lauryl Sulfate

Interventions

AN2718 OTHER

AN2718 Cream SF Vehicle, Daily for up to 21 days

A

Sodium Lauryl Sulfate OTHER

Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Also known as: SLS

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers of either sex, at least 18 years of age or older.
• 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.
• Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
• Willingness to follow the study procedures and complete the study.
• Written informed consent obtained.

You may not qualify if:

• Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
• Chronic asthma will be excluded.
• Pregnant or nursing mothers.
• A history of sensitivity to any component of any of the formulations.
• Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

The Education and Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

Sodium Dodecyl Sulfate

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)