Clinical evaluation of Double Strength Isotrexin versus Benzamycin in the topical treatment of mild to moderate acne vulgaris.
BACKGROUND
Topical retinoid therapy has been shown to be an effective means of treating both the inflammatory and non-inflammatory lesions of acne vulgaris.


OBJECTIVE
To assess the efficacy and safety of the test product, a gel containing isotretinoin 0.1% w/w and erythromycin 4.0% w/w, with a currently used and effective treatment for mild to moderate acne vulgaris, a gel containing benzoyl peroxide 5.0% w/w and erythromycin 3.0% w/w.


METHODS
This multi-centre, single-blind (investigator blind), parallel group study compared the efficacy and safety of isotretinoin/erythromycin gel (Double Strength Isotrexin) once daily against benzoyl peroxide/erythromycin gel (Benzamycin twice daily in the topical treatment of mild to moderate acne vulgaris. Patients (n = 188) with a history (mean duration 3.3 years) of facial acne vulgaris and with 15-100 inflammatory lesions and/or 15-100 non-inflammatory lesions, but not more than three nodulocystic lesions, were included. At baseline and weeks 2, 4, 8 and 12, the investigator assessed efficacy (total number and severity of inflammatory and non-inflammatory lesions and acne grade) while subjective global change assessments of facial acne from baseline and symptom-specific skin tolerance were assessed by the patient. The investigator recorded an overall global assessment of skin tolerability at week 12. Adverse events were recorded throughout.


RESULTS
The treatments were comparable with regard to their effects on inflammatory and non-inflammatory lesions and acne grade. Few adverse events were considered to be treatment-related. Both the isotretinoin/erythromycin and benzoyl peroxide/erythromycin gels were generally well tolerated. Compliance was better with the isotretinoin/erythromycin gel, which had the advantages of not requiring mixing or storage in a refrigerator, and was applied once rather than twice daily.


CONCLUSIONS
Isotretinoin/erythromycin gel given only once daily showed comparable efficacy with benzoyl peroxide/erythromycin given twice daily in the treatment of mild to moderate acne vulgaris of the face.
Marazzi
P
P
The Medical Centre, East Horsley, Surrey, UK.
Boorman
G C
GC
Donald
A E
AE
Davies
H D
HD
D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D004917:Erythromycin / Q000008:administration & dosage* / Q000009:adverse effects; D005782:Gels; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method
D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D004917:Erythromycin; D015474:Isotretinoin