Mode
Text Size
Log in / Sign up
N/A N=36 Randomized Single-blind Treatment

Patch Test of Benzalkonium Chloride Disinfectant Spray

Wound Healing

Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Proportion of Participants With Skin Irritation Scores at 24 Hours — 75.0; 91.7; 94.4; 94.4 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
0.13% Benzalkonium Chloride (Drug); SLS Solution (Drug); Normal Saline Water (Drug); Empty Finn Chamber (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Feb 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Participants With Skin Irritation Scores at 24 Hours
75.0; 91.7; 94.4; 94.4; 25.0; 8.3
PRIMARY
Proportion of Participants With Skin Irritation Scores at 48 Hours
77.8; 50.0; 100.0; 100.0; 22.2; 38.9
PRIMARY
Proportion of Participants With Skin Irritation Scores at 72 Hours
77.8; 61.1; 94.4; 100.0; 16.7; 22.2
SECONDARY
Skin Irritation Scores at 24 Hours
27; 24; 9; 2; 0; 0 0.0654
SECONDARY
Skin Irritation Scores at 48 Hours
28; 36; 8; 0; 0; 0 0.0078 sig
SECONDARY
Skin Irritation Scores at 72 Hours
28; 34; 6; 2; 2; 0 0.0547

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01762982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search