Imiquimod 5% cream for the treatment of actinic keratosis: results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology.
J Am Acad Dermatol
; 51(4): 547-55, 2004 Oct.
Article
em En
| MEDLINE
| ID: mdl-15389189
ABSTRACT
BACKGROUND:
Increasing evidence suggests imiquimod may be a safe therapeutic option for the treatment of actinic keratosis (AK). The diagnosis and assessment of most AK lesions is made clinically, without histologic confirmation.OBJECTIVE:
A phase III, randomized, double-blind, parallel group, vehicle-controlled study evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp including pretreatment and posttreatment biopsy specimens.METHODS:
A total of 286 patients at 18 centers in 6 European countries with histologically confirmed AK were randomized to either imiquimod 5% cream or vehicle cream. Study cream was applied once per day, 3 days per week, for 16 weeks. Clearance of AK lesions was clinically and histologically assessed at an 8-week posttreatment visit.RESULTS:
The complete clearance rate for the imiquimod group was 57.1% versus 2.2% for the vehicle group (P <.001). The partial clearance rate (> or =75% reduction in baseline lesions) for the imiquimod group was 72.1% versus 4.3% for the vehicle group (P <.001). The most common side effects were erythema, scabbing/crusting, and erosions/ulceration. For the imiquimod group the incidence of severe erythema, scabbing/crusting, or erosions/ulceration was 30.6%, 29.9%, and 10.2%, respectively.CONCLUSION:
Imiquimod 5% cream used 3 times per week for 16 weeks is an effective treatment for AK. Clinical clearance was established by both clinical observation and histologic analysis.
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Base de dados:
MEDLINE
Assunto principal:
Transtornos de Fotossensibilidade
/
Aminoquinolinas
/
Ceratose
Tipo de estudo:
Clinical_trials
Limite:
Aged
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Am Acad Dermatol
Ano de publicação:
2004
Tipo de documento:
Article
País de afiliação:
Alemanha