Patch Test of Benzalkonium Chloride Disinfectant Spray

NCT01762982 | Completed Results

• 1 other identifier: RH01379
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants With Skin Irritation Scores at 24 Hours

  Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.

  Baseline to 24 hours following product application

• Proportion of Participants With Skin Irritation Scores at 48 Hours

  Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.

  Baseline to 48 hours following first product application

• Proportion of Participants With Skin Irritation Scores at 72 Hours

  Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.

  Baseline to 72 hours following first product application

Secondary Outcomes (3)

• Skin Irritation Scores at 24 Hours

  Baseline to 24 hours following product application

• Skin Irritation Scores at 48 Hours

  Baseline to 48 hours following first product application

• Skin Irritation Scores at 72 Hours

  Baseline to 72 hours following first product application

Study Arms (4)

Test

EXPERIMENTAL

Benzalkonium chloride (0.13%) Disinfectant Spray water

Drug: 0.13% Benzalkonium Chloride

Positive Control

ACTIVE COMPARATOR

Sodium lauryl sulfate (SLS) (0.3% weight by weight \[w/w\]) water solution

Drug: SLS Solution

Negative Control 1

PLACEBO COMPARATOR

Normal saline water (0.9% weight by volume \[w/v\])

Drug: Normal Saline Water

Negative Control 2

PLACEBO COMPARATOR

Empty Finn Chamber

Other: Empty Finn Chamber

Interventions

0.13% Benzalkonium Chloride DRUG

Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution

Test

SLS Solution DRUG

Finn Chamber filled with SLS (0.3% w/v) water solution

Positive Control

Normal Saline Water DRUG

Finn Chamber filled with Normal Saline water (0.9% w/v)

Negative Control 1

Empty Finn Chamber OTHER

Empty Finn Chamber

Negative Control 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions, and will agree to not participate in any other study during the entire length of the study.
• General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history and vital signs at the screening.
• Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.

You may not qualify if:

• Pregnancy: Woman who is pregnant or who has a positive urine pregnancy test (just for females of childbearing potential) at the baseline.
• Breast-feeding: Woman who is breast-feeding.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials or have self-reported "sensitive skin" or a history of dermal hypersensitivity.
• Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, including those who have taken part in any predictive irritation study or sensitisation test.
• Substance abuse: Recent history (within the last 1 year) of alcohol or other substance abuse.
• Personnel: An employee of the sponsor or the study site or members of their immediate family.
• Participant who is currently taking any of the following medications:
• Any topical or systemic treatments that may mask or interfere with the test results, specifically topical and/or systemic corticosteroids, non steroidal anti-inflammatory drugs (e.g. ibuprofen, aspirin), antihistamines and immunosuppressive in the past 30 days. And those taking medications which in the opinion of the clinical investigator may affect test results.
• Topical anti-inflammation treatment in the aimed application area in the past 2 months.
• Participant who has a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., atopic dermatitis/eczema, systemic lupus erythematosus, rheumatoid arthritis, other autoimmune diseases, asthma and other chronic respiratory disease).
• \. Participant who has damaged skin in close proximity to test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, birthmarks or other disfigurations). And those who are suffering from any active skin disorders, conditions, or any visible skin disease which might be confused with a skin reaction from the test materials.
• \. Participant who requires use of any emollient on the upper back throughout the study or who use of any emollient or other skin care product on the upper back in the past 3 days.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

PeKing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

Benzalkonium Compounds; sodium lactobionate sucrose solution

Intervention Hierarchy (Ancestors)

Benzylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 8, 2013
• Study Start: February 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 22, 2014
• Results First Posted: January 22, 2014

Record last verified: 2013-07

Locations

CN (1)