Wound Healing Clinical Trial
Official title:
A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin
Verified date | July 2013 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Review Board |
Study type | Interventional |
The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.
Status | Completed |
Enrollment | 36 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | PeKing University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
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