Safety and tolerability in the MORE trial

Cutis. 2006 Jul;78(1 Suppl):19-25.

Abstract

Adverse events and a high potential for cutaneous irritation may have a negative effect on patient adherence to acne treatments, the primary factor contributing to optimal outcomes. In addition to effectiveness and subject satisfaction, the Measuring Acne Outcomes in a Real-World Experience (MORE) trial evaluated adverse events and cutaneous tolerability of adapalene gel 0.1% in 1396 subjects who received initial combination therapy with adapalene gel 0.1% and 468 subjects who added adapalene gel 0.1% to their existing regimen (safety population). Adverse events were uncommon (reported by 5.8% of subjects) and generally mild, the most frequent being skin and subcutaneous tissue disorders (2.7%). Overall, investigators rated cutaneous tolerability as high. Adherence to therapy also was high with both the initial combination and add-on therapies. The MORE trial confirms that adapalene gel 0.1% is safe and well tolerated and therefore likely to enhance adherence to treatment and the likelihood of optimal treatment outcomes for patients with moderate to moderately severe acne.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adapalene
  • Administration, Topical
  • Adolescent
  • Adult
  • Child
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Naphthalenes / administration & dosage
  • Naphthalenes / adverse effects*
  • Naphthalenes / therapeutic use
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Naphthalenes
  • Adapalene