Wound HealingNCT01762982

Patch Test of Benzalkonium Chloride Disinfectant Spray

A study testing 0.13% Benzalkonium Chloride, SLS Solution and Normal Saline Water in people with Wound Healing, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Wound Healing
What is being tested?: 0.13% Benzalkonium Chloride, SLS Solution and Normal Saline Water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteChina
Study dates: Feb 2012to Feb 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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).
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 locations and contacts

1 site in 1 country.

China1 site

PeKing University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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

Read the 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).

Conditions: Wound Healing
Being tested: 0.13% Benzalkonium Chloride, SLS Solution, Normal Saline Water, Empty Finn Chamber

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.13% Benzalkonium ChlorideDrug
Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
SLS SolutionDrug
Finn Chamber filled with SLS (0.3% w/v) water solution
Normal Saline WaterDrug
Finn Chamber filled with Normal Saline water (0.9% w/v)
Empty Finn ChamberOther
Empty Finn Chamber

Study groups in NCT01762982
Study group	Role	What they receive
Test	Experimental	Benzalkonium chloride (0.13%) Disinfectant Spray water Receives: Drug: 0.13% Benzalkonium Chloride
Positive Control	Active comparator	Sodium lauryl sulfate (SLS) (0.3% weight by weight [w/w]) water solution Receives: Drug: SLS Solution
Negative Control 1	Placebo comparator	Normal saline water (0.9% weight by volume [w/v]) Receives: Drug: Normal Saline Water
Negative Control 2	Placebo comparator	Empty Finn Chamber Receives: Other: Empty Finn Chamber

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 24 hours following product application
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.
Measured: Baseline to 48 hours following first product application
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.
Measured: Baseline to 72 hours following first product application

Secondary outcomes (3)

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.
Measured: Baseline to 24 hours following product application
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.
Measured: Baseline to 48 hours following first product application
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.
Measured: Baseline to 72 hours following first product application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Feb 2012

First posted8 Jan 2013 (estimated)
Study startFeb 2012
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Wound HealingStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01762982
Sponsor's protocol ID: RH01379
Status last verified: Jul 2013
First submitted: 4 Jan 2013
Last updated: 22 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Centre, Examiner-blind Human Patch Test of Bactroban Disinfectant Liquid on Normal Skin
ClinicalTrials.gov ID: NCT01762982
Acronym / sponsor ID: RH01379
Conditions: Wound Healing
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 8 Jan 2013 (estimated)
Results: Posted 22 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Test	Experimental	Drug: 0.13% Benzalkonium ChlorideBenzalkonium chloride (0.13%) Disinfectant Spray water
Positive Control	Active comparator	Drug: SLS SolutionSodium lauryl sulfate (SLS) (0.3% weight by weight [w/w]) water solution
Negative Control 1	Placebo comparator	Drug: Normal Saline WaterNormal saline water (0.9% weight by volume [w/v])
Negative Control 2	Placebo comparator	Other: Empty Finn ChamberEmpty Finn Chamber

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.13% Benzalkonium ChlorideFinn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution	Drug	Test
SLS SolutionFinn Chamber filled with SLS (0.3% w/v) water solution	Drug	Positive Control
Normal Saline WaterFinn Chamber filled with Normal Saline water (0.9% w/v)	Drug	Negative Control 1
Empty Finn ChamberEmpty Finn Chamber	Other	Negative Control 2

Primary outcome

Proportion of Participants With Skin Irritation Scores at 24 Hours
Time frame: Baseline to 24 hours following product application
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
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
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.

3 secondary outcomes

Skin Irritation Scores at 24 Hours
Time frame: Baseline to 24 hours following product application
Skin Irritation Scores at 48 Hours
Time frame: Baseline to 48 hours following first product application
Skin Irritation Scores at 72 Hours
Time frame: Baseline to 72 hours following first product application

Results and safety

Results posted to the registry on 22 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	36	36

Primary outcome: Proportion of Participants With Skin Irritation Scores at 24 Hours

Time frame: Baseline to 24 hours following product application. Number. Unit: Percentage of participants

Measure	Benzalkonium Chloride Solution n = 36	SLS Solution n = 36	Normal Saline Water n = 36	Empty Finn Chamber n = 36
Score = 0 (No Visible Skin Reaction)	75.0	91.7	94.4	94.4
Score = 1 (Weak Erythema)	25.0	8.3	5.6	5.6
Score = 2 (Erythema, Infiltration, Papule)	0	0	0	0
Score = 3 (Erythema, Edema, Papule, Blister)	0	0	0	0
Score = 4 (Erythema, Edema, Extreme Blistering)	0	0	0	0

Population analysed: Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.

Primary outcome: Proportion of Participants With Skin Irritation Scores at 48 Hours

Time frame: Baseline to 48 hours following first product application. Number. Unit: Percentage of participants

Measure	Benzalkonium Chloride Solution n = 36	SLS Solution n = 36	Normal Saline Water n = 36	Empty Finn Chamber n = 36
Score = 0 (No Visible Skin Reaction)	77.8	50.0	100.0	100.0
Score = 1 (Weak Erythema)	22.2	38.9	0	0
Score = 2 (Erythema, Infiltration, Papule)	0	11.1	0	0
Score = 3 (Erythema, Edema, Papule, Blister)	0	0	0	0
Score = 4 (Erythema, Edema, Extreme Blistering)	0	0	0	0

Population analysed: ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.

Primary outcome: Proportion of Participants With Skin Irritation Scores at 72 Hours

Time frame: Baseline to 72 hours following first product application. Number. Unit: Percentage of participants

Measure	Benzalkonium Chloride Solution n = 36	SLS Solution n = 36	Normal Saline Water n = 36	Empty Finn Chamber n = 36
Score = 0 (No Visible Skin Reaction)	77.8	61.1	94.4	100.0
Score = 1 (Weak Erythema)	16.7	22.2	5.6	0
Score = 2 (Erythema, Infiltration, Papule)	5.6	16.7	0	0
Score = 3 (Erythema, Edema, Papule, Blister)	0	0	0	0
Score = 4 (Erythema, Edema, Extreme Blistering)	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the start of the investigational product and until 5 days following last administration of the investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	0 of 36 (0%)	3 of 36 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 0.13% Benzalkonium Chloride, SLS Solution and Normal Saline Water in people with Wound Healing, run by GlaxoSmithKline at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Skin Irritation Scores at 24 Hours (time frame: Baseline to 24 hours following product application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01762982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.