A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

NCT00731042 | Completed Phase 4 Results

• 1 other identifier: I2MS05-010877
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Conditions

Healthy

Keywords

Skin health

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days

  Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).

  Baseline and 14 days

Study Arms (2)

Avagard

EXPERIMENTAL

3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers

Drug: Avagard

Purell

ACTIVE COMPARATOR

Purell Surgical Scrub with Moisturizers

Drug: Purell Surgical Scrub

Interventions

Avagard DRUG

Topical solution, 6 mL, 6 applications/day for 14 days.

Avagard

Purell Surgical Scrub DRUG

Topical solution, 4 mL, 6 applications/day for 14 days.

Also known as: Purell Surgical Scrub with Moisturizers

Purell

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female age 25 - 55
• Subject agrees not to use any hand wash products on their hands other than what has been provided in the study.
• Subject agrees not to use any moisturizers or any skin products on their hands during the study
• Subject agrees to use gloves to protect hands from activities such as dish washing
• Subject is willing to sign the Informed Consent and HIPAA
• Subject agrees to comply with the study requirement

You may not qualify if:

• Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands
• Subject has scaly skin on hands based on Visual Scoring Scale at Day 1
• Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)
• Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study
• Subject is pregnant

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

MeSH Terms

Interventions

chlorhexidine gluconate

Results Point of Contact

• Title: Chou Eyberg
• Organization: 3M Company

cieyberg1@mmm.com

651-737-0934

Study Officials

• Gary L Grove, PhD

  cyberDERM Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 2, 2024
• Results First Posted: June 17, 2009

Record last verified: 2024-11