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Página de Inicio arrow Artículos Científicos arrow Study of the Efficacy and Tolerability of 0.04% Tretinoin Microsphere Gel for Preadolescent Acne
Study of the Efficacy and Tolerability of 0.04% Tretinoin Microsphere Gel for Preadolescent Acne Imprimir E-Mail
Published online May 24, 2010
PEDIATRICS Vol. 125 No. 6 June 2010, pp. e1316-e1323 (doi:10.1542/peds.2009-3447)
ARTICLES
Study of the Efficacy and Tolerability of 0.04% Tretinoin Microsphere Gel for Preadolescent Acne
Lawrence F. Eichenfield, MDa, Catalina Matiz, MDa,Ann Funk, RNa, Sara W. Dill, MDb
a Department of Pediatric and Adolescent Dermatology, Rady Children's Hospital San Diego, University of California, San Diego, California; and
b Department of Dermatology, Brown Medical School, Brown University, Providence, Rhode Island

OBJECTIVES The goals were to assess the degree of improvement of facial acne after treatment with the 0.04% tretinoin microsphere gel (TMG) among patients 8 to 12 years of age and to assess tolerability and safety.

METHODS An open-label study was conducted with 40 patients 8 to 12 years of age (mean age: 10.7 years) with mild/moderate acne, defined on the basis of Evaluator's Global Severity Score (EGSS) valuesbetween 2 and 3. Patients were treated with the 0.04% TMG for 12 weeks and were evaluated at baseline and weeks 3, 6, and 12. Primary end points were changes in EGSS and Alternative Evaluator's Global Severity Score values; the secondary efficacy end point was the Investigator's Global Evaluation of treatment responses at week 12.

RESULTS The mean EGSS value decreased significantly from baseline to week 12 (2.6 vs 2.1; P < .001), with 75% of cases being graded as almost clear or mild. The mean Alternative Evaluator's Global Severity Score value decreased from 3.1 to 2.4 during the 12-week period (P < .001). The mean Investigator's Global Evaluation score was 3.39 at week 12, indicating moderate improvement of acne. Treatment-associated adverse events were minimal, with mild skin irritation being most commonly recorded, generally in the first 3 weeks of therapy.

CONCLUSIONS The 0.04% TMG pump was effective and safe for the treatment of acne vulgaris in this 8- to 12-year-old population, and the treatment was generally well tolerated. Additional studies inthis population are recommended, to confirm these results.

Key Words: pediatric acne • preadolescent acne • tretinoin

Abbreviations: AEGSS = Alternative Evaluator's Global Severity Score • EGSS = Evaluator's Global Severity Score • IGE = Investigator's Global Evaluation • TMG = tretinoin microsphere gel • ITT = intent-to-treat

Accepted Feb 23, 2010.
 
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