A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

NCT03140254

Preoperative Skin Preparation

COMPLETED PHASE2

"Clinical Trials to Enhance Elders' Oral Health" ("TEETH")

NCT00004640

Tooth Loss Periodontal Disease Tooth Decay

COMPLETED PHASE3

The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

NCT02939092

Gingival Bleeding

UNKNOWN NA

A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

NCT00655772

Halitosis

COMPLETED PHASE1

Phase 2, Safety & Microbiology Study of C16G2 in Multiple Oral Gel &/or Mouth Rinse Doses to Healthy Adults

NCT02044081

Dental Caries

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prototype disinfectant spray formulation

0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Group Type EXPERIMENTAL

Prototype disinfectant spray formulation

Intervention Type OTHER

0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Reference product

0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Group Type ACTIVE_COMPARATOR

Reference product

Intervention Type OTHER

0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Negative control

0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Group Type PLACEBO_COMPARATOR

Negative control

Intervention Type OTHER

0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prototype disinfectant spray formulation

0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Intervention Type OTHER

Reference product

0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Intervention Type OTHER

Negative control

0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants in good health with healthy and intact skin on the test area
* Age 18-60 years

Exclusion Criteria

* Pregnancy or breast-feeding
* Allergy/Intolerance
* Participants currently taking any topical or systemic treatments that may interfere with or mask the test results
* Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months
* Participants who are vulnerable to any intervention
* Damaged skin close to test site, active skin disorders, any visible skin disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes