Last updated: 11/04/2018 10:25:51
Patch Test of Benzalkonium chloride disinfectant spray
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin
Trial description: The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Proportion of participants with skin irritation scores at 24 hours
Timeframe: Baseline to 24 hours following product application
Proportion of participants with skin irritation scores at 48 hours
Timeframe: Baseline to 48 hours following first product application
Proportion of participants with skin irritation scores at 72 hours
Timeframe: Baseline to 72 hours following first product application
Secondary outcomes:
Skin irritation scores at 24 hours
Timeframe: Baseline to 24 hours following product application
Skin irritation scores at 48 hours
Timeframe: Baseline to 48 hours following first product application
Skin irritation scores at 72 hours
Timeframe: Baseline to 72 hours following first product application
Interventions:
Drug: 0.13% Benzalkonium Chloride
Drug: SLS Solution
Drug: Normal Saline Water
Other: Empty Finn Chamber
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
2012-29-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Wound Healing
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2012 to February 2012
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
PeKing University First Hospital
Beijing, Beijing, China, 100034
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-29-02
Actual study completion date
2012-29-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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