High-dose isotretinoin treatment and the rate of retrial, relapse, and adverse effects in patients with acne vulgaris.

Abstract

IMPORTANCE:

Isotretinoin is the most effective treatment for acne. The ideal dosing regimen is unknown.

OBJECTIVE:

To determine the rates of relapse of acne vulgaris and retrial of isotretinoin after high cumulative-dose treatment and the changes to the adverse effect profile.

DESIGN, SETTING, AND PARTICIPANTS:

A prospective, observational, intervention study was conducted from August 1, 2008, to August 31, 2010, in a single academic tertiary care center with multiple providers. A total of 180 patients with acne resistant to other treatments were enrolled. Of these, 116 participated in the 12-month follow-up survey, for a response rate of 64.4%.

EXPOSURE:

Patients received isotretinoin, with dosing based on the providers' judgment. Patients were divided into 2 groups on the basis of cumulative dosing (<220 mg/kg and ≥ 220 mg/kg).

MAIN OUTCOMES AND MEASURES:

Relapse (treatment with a prescription topical or oral acne medication after a course of isotretinoin) or retrial (retreatment with isotretinoin) at 12-month follow-up and adverse effects experienced during and after 12 months of treatment. RESULTS The mean age of the participants was 19.3 years, 51.9% were female, and 74.1% were white. At 12 months' follow-up, 97.4% of the patients reported that their acne was improved. Overall, acne in 32.7% of patients in the study relapsed at 12 months, and 1.72% of the patients required a retrial. In the lower-dose treatment group (<220 mg/kg), the relapse rate was 47.4% (95% CI, 32.3%-63.0%) compared with 26.9% (95% CI, 18.3%-37.8%) in the high-dose group (P = .03). Almost 100% of the patients in both treatment groups developed cheilitis and xerosis during treatment. Retinoid dermatitis was significantly more common in the high-dose treatment group (53.8% vs 31.6%; P = .02). None of the other adverse effects was significantly different between the 2 groups.

CONCLUSIONS AND RELEVANCE:

The dosing regimen used in the present study is considerably higher than that used in previous studies of isotretinoin. At 1 year after completion of isotretinoin treatment, we found that patients receiving 220 mg/kg or more had a significantly decreased risk of relapse. Rash was the only adverse effect that was significantly more common in the high-dose group during treatment. This study suggests that significantly higher doses of isotretinoin are effective for treating acne and decreasing relapse rates without increasing adverse effects.

• Authors: Rachel C Blasiak, Christopher R Stamey, Craig N Burkhart, Aida Lugo-Somolinos, Dean S Morrell
• Journal: JAMA dermatology (JAMA Dermatol) Vol. 149 Issue 12 Pg. 1392-8 (Dec 2013) ISSN: 2168-6084 [Electronic] United States
• PMID: 24173086 (Publication Type: Journal Article, Observational Study)

Chemical References

• Dermatologic Agents
• Isotretinoin

Topics

• Acne Vulgaris (drug therapy, pathology)
• Adolescent
• Adult
• Child
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Eruptions (etiology, pathology)
• Female
• Follow-Up Studies
• Humans
• Isotretinoin (administration & dosage, adverse effects, therapeutic use)
• Male
• Prospective Studies
• Recurrence
• Retreatment
• Treatment Outcome
• Young Adult