Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Efficacy and Safety in Patients Aged 9 Years and Older.

Abstract

BACKGROUND:

Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines.

OBJECTIVE:

To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older.

METHODS:

A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed.

RESULTS:

Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and 'clear' or 'almost clear' was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events.

LIMITATIONS:

Data from controlled studies may differ from clinical practice.

CONCLUSIONS:

Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.

• Authors: Stephen K Tyring, Leon H Kircik, David M Pariser, Eric Guenin, Varsha Bhatt, Radhakrishnan Pillai
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 17 Issue 10 Pg. 1084-1091 (Oct 01 2018) ISSN: 1545-9616 [Print] United States
• PMID: 30365589 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Keratolytic Agents
• Tretinoin

Topics

• Acne Vulgaris (drug therapy, pathology)
• Administration, Cutaneous
• Adolescent
• Adult
• Child
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Keratolytic Agents (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Quality of Life
• Severity of Illness Index
• Skin Cream
• Surveys and Questionnaires
• Treatment Outcome
• Tretinoin (administration & dosage, therapeutic use)
• Young Adult