By Perrie Susman
MIAMI BEACH, Fla -- March 9, 2010 -- The use of a tretinoin gel microsphere pump appears to be effective in reducing acne that occurs among preteen boys and girls, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD).
"Although acne vulgaris is a disease typically seen in teenagers, it is also common in preadolescence and early adolescence," said Catalina Matiz, MD, Rady Children's Hospital, San Diego, California, during a poster presentation on March 8.
Dr. Matiz said that treatment in the preadolescent population is not currently addressed by standard guidelines. While topical retinoids are recommended as first-line treatment of acne, she said that few data on retinoid use in preadolescent patients exist.
Tretinoin gel microsphere pump 0.04% has been proven effective in the treatment of both inflammatory and noninflammatory acne lesions and has demonstrated favourable safety and tolerability profiles. It has not previously been studied in a paediatric population.
Dr. Matiz and colleagues enrolled 40 children (33 girls) aged 8 to 12 years with mild to moderate acne -- defined as an Evaluator's Global Severity Score (EGSS) between 2 and 3 (scale of 0-5). Patients were instructed to apply 2 full pumps of tretinoin gel microsphere 0.04% to the affected facial areas once daily in the evening. Patients were also provided with facial cleanser, moisturiser, and sunscreen.
In the intention to treat population, Dr. Matiz observed the mean EGSS at week 12 improved from 2.6 at baseline to 2.1 (P < .001) and the mean Alternative EGSS both improved significantly at week 12 from a baseline score of 3.1 to 2.4 (P < .001).
Of the 36 who completed the study, 18 (50%) had improved by 1 EGSS grade, 18 were unchanged, and none worsened. In the Alternative EGSS assessment, 5 (13.9%) of the patients improved by 2 grades, 15 (41.7%) improved by 1 grade, 16 (44.4%) were unchanged, and none had worsened.
A total of 27 patients experienced an adverse event. Treatment-related adverse events were seen in 15 patients and generally lasted less than 1 week. Mild skin irritation was the most commonly reported treatment-related adverse event, occurring in 12 patients.
"There were no discontinuations due to adverse events," Dr. Matiz reported. "However, 1 patient discontinued due to worsening of acne."
Funding for this study was provided by Ortho Dermatologics.
[Presentation title: An Open-Label Study to Assess Efficacy and Tolerability of Tretinoin Gel Microsphere 0.04% in a Pump Dispenser in Early and Preadolescents. Abstract 714]
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