Patch Test of Benzalkonium Chloride Disinfectant Spray

Wound Healing Clinical Trial

Official title:

A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762982
• Other study ID #: RH01379
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: December 5, 2013
• Start date: February 2012
• Est. completion date: February 2012

Study information

• Verified date: July 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing

Intervention

Drug:
• 0.13% Benzalkonium Chloride
Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
• SLS Solution
Finn Chamber filled with SLS (0.3% w/v) water solution
• Normal Saline Water
Finn Chamber filled with Normal Saline water (0.9% w/v)

Other:
• Empty Finn Chamber
Empty Finn Chamber

Locations

Country	Name	City	State
China	PeKing University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

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