Patch Test of Benzalkonium Chloride Disinfectant Spray

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01762982
First received: January 4, 2013
Last updated: December 5, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Wound Healing
Drug: 0.13% Benzalkonium Chloride
Drug: SLS Solution
Drug: Normal Saline Water
Other: Empty Finn Chamber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of Participants With Skin Irritation Scores at 24 Hours [ Time Frame: Baseline to 24 hours following product application ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Participants With Skin Irritation Scores at 48 Hours [ Time Frame: Baseline to 48 hours following first product application ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Participants With Skin Irritation Scores at 72 Hours [ Time Frame: Baseline to 72 hours following first product application ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Skin Irritation Scores at 24 Hours [ Time Frame: Baseline to 24 hours following product application ] [ Designated as safety issue: Yes ]
    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.

  • Skin Irritation Scores at 48 Hours [ Time Frame: Baseline to 48 hours following first product application ] [ Designated as safety issue: Yes ]
    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.

  • Skin Irritation Scores at 72 Hours [ Time Frame: Baseline to 72 hours following first product application ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Benzalkonium chloride (0.13%) Disinfectant Spray water
Drug: 0.13% Benzalkonium Chloride
Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
Active Comparator: Positive Control
Sodium lauryl sulfate (SLS) (0.3% weight by weight [w/w]) water solution
Drug: SLS Solution
Finn Chamber filled with SLS (0.3% w/v) water solution
Placebo Comparator: Negative Control 1
Normal saline water (0.9% weight by volume [w/v])
Drug: Normal Saline Water
Finn Chamber filled with Normal Saline water (0.9% w/v)
Placebo Comparator: Negative Control 2
Empty Finn Chamber
Other: Empty Finn Chamber
Empty Finn Chamber

Detailed Description:

Benzalkonium chloride is recognized as safe and effective for short term use as first aid antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be compared to a positive control, and two negative control for irritancy potential on normal skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin irritation assessment will characterize the test products individually in terms of symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4 (Erythema,edema˛ extreme blistering).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.

Exclusion Criteria:

  1. Pregnancy: Woman who is pregnant or who has a positive urine pregnancy test (just for females of childbearing potential) at the baseline.
  2. Breast-feeding: Woman who is breast-feeding.
  3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials or have self-reported "sensitive skin" or a history of dermal hypersensitivity.
  4. 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.
  5. Substance abuse: Recent history (within the last 1 year) of alcohol or other substance abuse.
  6. Personnel: An employee of the sponsor or the study site or members of their immediate family.
  7. 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.
  8. 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).

10. 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.

11. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762982

Locations
China, Beijing
PeKing University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01762982     History of Changes
Other Study ID Numbers: RH01379
Study First Received: January 4, 2013
Results First Received: July 25, 2013
Last Updated: December 5, 2013
Health Authority: China: Ethics Review Board

Additional relevant MeSH terms:
Benzalkonium Compounds
Disinfectants
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014