D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

other information

Study period:

2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study in French with English summary

Data source

Reference

Reference Type:

publication

Title:

Tolérance clinique des antiseptiques cutanés chez 3403 malades en pratique de ville

Author:

Caumes E, Le Maitre M, Garnier JM, Bricaire F & Crickx B

Year:

2006

Bibliographic source:

Ann Dermatol Veneorol 133, 755-760

Materials and methods

Study type:

other: Prevalence of adverse cutaneous reactions

Endpoint addressed:

other: Prevalence of adverse cutaneous reactions

Test material

Test material information

Constituent 1

Reference substance name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

EC Number:

242-354-0

EC Name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

Cas Number:

18472-51-0

Molecular formula:

C22H30Cl2N10.2C6H12O7

IUPAC Name:

N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)

Method

Details on study design:

The prevalence and the clinical forms of adverse cutaneous reactions were studied which are associated with the main antiseptics used in France. 3403 patients (mean age: 47 years; 61 % women; 39 % men) were included in the study. The patients for whom ambulatory treatment with a cutaneous antiseptic was performed were recruited from 773 French dermatologists during May and June 2003. Adverse reactions as reported by the patient in person or at telephone interview were validated by two independent experts.

Results and discussion

Results:

Among the 6 most widely used treatments (96 % of prescriptions), there were several containing chlorhexidine alone or in combination: chlorhexidine-benzalkonium (28 %), chlorhexidine-alcohol (16.5 %), aqueous chlorhexidine (7 %), and hexamidine-chlorhexidine (1.8 %). Of all patients treated, 4 to 7 % noticed a burning sensation, there was no significant difference between antiseptics. Detailed examination revealed 10 adverse events (9 with persistent burning sensation, one with contact dermatitis) (overall prevalence: 2.9/1000, ranging from 0-0.5 % for the various antiseptics). A history of contact dermatitis was associated with a risk of an adverse reaction (OR:7.2; 95 % C.I. 2-26.4).
There were no significant differences for the reactions between the different antiseptics.

Applicant's summary and conclusion

Executive summary:

In this study, adverse skin reactions following the topical administration of antiseptics were studied in dermatological patients. A number of the antiseptics contained chlorhexidine, mostly in combination with other compounds.

No differences were noted between the different antiseptics. The results of the study indicate that adverse reactions of the skin following topical administration of antiseptics including chlorhexidine is a very rare event.