Phase 4 study to assess tretinoin pump for the treatment of facial acne

Lawrence F. Eichenfield*, Marge Nighland, Ana Beatris Rossi, Fran Cook-Bolden, Pearl Grimes, Richard Fried, Sharon Levy, A. Barba, E. Battle, L. Baumann, R. Brodell, A. Bucko, C. Burkhart, V. Callender, F. Cook-Bolden, K. Dawes, J. Del Rosso, J. Dosik, J. Downie, L. EichenfieldP. English, D. Forsha, J. Fowler, R. Fried, T. Funicella, L. Gold, M. Gold, P. Grimes, A. Gross, D. Kaplan, L. Kircik, J. Leyden, K. Loven, A. Lucky, A. Paller, E. Rafal, D. Rodriquez, N. Sadick, J. Schlessinger, F. Schiavone, J. Shavin, J. Spencer, E. Spiers, S. Taylor, W. Werschler, D. Wilson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


It is well known that the setting of clinical trials for registration studies do not necessarily represent efficacy seen in clinical practice, where physicians have the flexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label, multicenter, community-based study, 544 patients who were dissatisfied with their current acne treatment received tretinoin gel microsphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was high (defined as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At week 12, the mean modified Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated significant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compliance.

Original languageEnglish (US)
Pages (from-to)1129-1136
Number of pages8
JournalJournal of Drugs in Dermatology
Issue number12
StatePublished - Dec 2008

ASJC Scopus subject areas

  • Medicine(all)


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