14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

NCT02309294 | Completed Results

• 1 other identifier: ST-7553
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.

Conditions

Cumulative Irritation

Keywords

Patch Test

Outcome Measures

Primary Outcomes (1)

• Number of Subjects That Showed no Significant Irritation

  Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).

  14 days

Study Arms (1)

Healthy Subject

EXPERIMENTAL

Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).

Device: Novel lubricant Miami w/ fragrance; Device: Novel lubricant Miami no fragrance; Device: KY Liquid lubricant; Device: Astroglide Gel lubricant; Device: Wet Platinum lubricant

Interventions

Novel lubricant Miami w/ fragrance DEVICE

0.2 ml aliquot on occlusive patch

Healthy Subject

Novel lubricant Miami no fragrance DEVICE

0.2 ml aliquot on occlusive patch

Healthy Subject

KY Liquid lubricant DEVICE

0.2 ml aliquot on occlusive patch

Healthy Subject

Astroglide Gel lubricant DEVICE

0.2 ml aliquot on occlusive patch

Healthy Subject

Wet Platinum lubricant DEVICE

0.2 ml aliquot on occlusive patch

Healthy Subject

Eligibility Criteria

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

You may qualify if:

• Are a male or female, 18 years of age or older, in general good health;
• Have normal skin;
• Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
• Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
• Complete a medical screening procedure; and
• Read, understand, and sign an informed consent.

You may not qualify if:

• Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
• Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
• Have psoriasis and/or active atopic dermatitis/eczema; and/or
• Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Results Point of Contact

• Title: Annahita Ghassemi
• Organization: Church & Dwight Co., Inc.

annahita.ghassemi@churchdwight.com

6098061200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-10

Locations

US (1)