Double-Blinded, Vehicle-Controlled Proof of Concept Study to Investigate the Recurrence of Inflammatory and Noninflammatory Acne Lesions Using Tretinoin Gel (Microsphere) 0.04% in Male Patients after Oral Isotretinoin Use

Abstract

Background. Although isotretinoin orally is commonly used for moderate to severe or scarring acne, it is not a cure. Unfortunately recurrence is unpredictable and varies within the acne population. Objectives. Using a proof of concept study, determine the recurrence of acne after isotretinoin use in male patients. Methods. Twenty males aged 18–45 years old were enrolled. Subjects successfully completed a treatment of acne vulgaris with oral isotretinoin (120–150 mg/kg/course). Subjects were randomized 1 to 1. The study duration was 24 weeks. The primary endpoint measured was the absolute change in lesion counts from baseline to weeks 16 and 24. Local tolerability assessments were measured. Results. There were favorable changes in all outcomes measured. Overall, there was a 38.7% lower lesion count with tretinoin 0.04% microsphere gel use versus vehicle. The active product was well tolerated with great patient satisfaction. There were no significant safety issues. The limitations included the low number of patients enrolled, average age, and percentage of patients lost to follow-up. Conclusion. In summary, the results favored tretinoin 0.04% microsphere gel in the prevention of recurrent acne after isotretinoin use in male patients over 18 years old over a six-month period.

Assessment of the Efficacy and Safety of a Combination of 2 Topical Retinoids (RetinSphere) in Maintaining Post-Treatment Response of Acne to Oral Isotretinoin

“…3,11,12 Likewise, this study confirms that maintenance therapy with retinoids after discontinuation of oral isotretinoin with residual acne lesions can reduce both non-inflammatory and inflammatory lesions. To prevent such relapses, this new retinoid combination has proven effective and is able to significantly improve acne lesions compared with baseline and with treatment with vehicle.…”

Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients

“…Subjects were excluded if patients had previously received benzoyl peroxide, tretinoin and/or oral retinoid containing products, patients had received oral antibiotics in the past 4 weeks, patients with endocrine disorders, or with severe physical illnesses, patients who were currently using oral contraceptives, or implantable contraceptives, patients who were using any systemic medications likely to affect (flaring or healing it up) such as oral phenytoin, finasteride, spironolactone, flutamide, testosterone or dietary body-building protein powders or patients who used topical, systemic, inhaled or intraocular corticosteroids within the past 4 weeks (Marcinkiewicz et al, 2008;Emanuele et al, 2012;Vender, 2012). This study was approved by the Research Ethics Committee Office of Faculty of Medicine, Cairo University, which followed the tenets of the Declaration of Helsinki (http://www.wma.net/en/20activities/10ethics/10helsinki/, 2013).…”

Maintenance Therapy for Acne Vulgaris: Efficacy of a 12-Month Treatment with Adapalene-Benzoyl Peroxide after Oral Isotretinoin and a Review of the Literature

“…Vender and Vender [36] recently published a double-blinded, vehicle-controlled proof of concept study investigating the recurrence of acne lesions using tretinoin gel 0.04% after OI. At the end of the 24 weeks of maintenance treatment, the group applying the active agent (7 patients) presented a mean acne lesion count of 1.2.…”