Pharmacotherapy Update: Facial and Truncal Acne Vulgaris: Increasing the Effects of Therapy - By James Q. Del Rosso, D.O., F.A.O.C.D. Adding a cleanser formulation of benzoyl peroxide to a regimen of oral antibiotic therapy can increase reduction of inflammatory lesions. Despite an overall paucity of data regarding the clinical efficacy of benzoyl peroxide (BP) cleanser formulations in treating acne vulgaris, the therapeutic benefit of some BP cleanser formulations has been demonstrated, as evidenced by reduced colony counts of Propionibacterium acnes and fewer numbers of acne lesions.1-3 This article reports on results of a new study that evaluated whether adding a BP cleanser to the existing regimen of an oral antibiotic therapy with either minocycline or doxycycline improved treatment for patients who had acne vulgaris affecting the face and/or trunk. The study methodology and results are discussed in detail. Previous Studies As mentioned above, other studies have indicated a therapeutic benefit from some BP cleanser formulations in treating facial and truncal acne vulgaris. These studies have included the following: • In a 12-week study of patients with facial acne vulgaris, a combination of BP 6% cleanser (Triaz) and tretinoin 0.1% microsphere gel (Retin A Micro), both used once daily, produced a 58.5% inflammatory lesion reduction at study endpoint as compared to 29.8% with tretinoin 0.1% microsphere gel used as monotherapy once a day.1 • In an open-label, randomized, 8-week trial of patients with moderate truncal acne vulgaris (n=40), use of a brand BP cleanser/wash formulation used once daily, utilizing either BP 9% cleanser (Triaz) or BP 8% wash (Brevoxyl Creamy Wash), used in combination with clindamycin phosphate 1% foam (Evoclin) applied once daily, was shown to produce at least moderate clearance in 92.5%, marked clearance in 60%, and near or complete clearance in 30% of subjects.4,5 A New Study Evaluating BP Cleanser in Combination with Oral Antibiotic Therapy In a 10-week, investigator-blinded, randomized trial, BP 6% cleanser (Triaz) for face or BP 9% cleanser (Triaz) for trunk, vs. a nontherapeutic cleanser, were compared in patients receiving oral antibiotic therapy with either minocycline or doxycycline for acne vulgaris affecting the face and/or trunk. Patients were evaluated at week 2, week 6 and week 10. Efficacy parameters included investigator global assessment (IGA), subject global assessment (SGA) and inflammatory, non-inflammatory and total lesion counts. Safety and tolerability assessments were also recorded.   Study Details Investigator-blinded, randomized, 10-week trial • Investigators were blinded with regard to which cleanser each subject was using throughout the trial. • Patients were evaluated at baseline and weeks 2, 6 and 10 (+/- 5-day window). 40 patients enrolled with facial and truncal acne vulgaris • 22 females/18 males 34 patients completed the trial • 20 females/14 males • 19 Caucasian/6 Hispanic/5 Asian/4 African-American • Age range 16 to 31 years • Mean age 22 years • One female patient on oral minocycline discontinued treatment due development of dizziness. • Two male patients stopped therapy due to gastrointestinal upset associated with oral doxycycline use. • Three subjects were lost to follow-up, two due to difficulty with appointment scheduling due to school and sports activities, and one for unknown reasons. Study Groups • Group 1 (n=18): BP 6% cleanser once daily for face, BP 9% cleanser once daily for trunk, minocycline 100 mg twice daily (n=9) or doxycycline 100 mg twice daily (n=9). • Group 2 (n=16): Nontherapeutic brand gentle liquid cleanser for face, nontherapeutic brand gentle liquid cleanser for trunk, minocycline 100 mg twice daily (n=9) or doxycycline 100 mg twice daily (n=7). • All patients utilized the same standardized brand gentle skin cleanser at other times of day when needed for cleansing purposes. • Sunscreen use was allowed during the study, but other topical products to the face and trunk were not, including moisturizers. Target Areas for Assessment • Face: The target area for assessment on the face was the forehead, cheeks, nose and chin. • Trunk: The target area on the trunk was defined as the area of the back bounded above by cervical spine 7 (C7), below by a horizontal line drawn from thoracic spine 7 (T7) through the bottom point of the scapula bilaterally, and laterally on each side by the peripheral edge of the shoulder and posterior axillary line. Inclusion Criteria • patients with acne vulgaris >16 years of age. • facial acne vulgaris • >10 superficial inflammatory lesions (papules, pustules) with <3 nodules • >10 non-inflammatory lesions (comedones). • truncal acne vulgaris • >12 superficial inflammatory lesions (papules, pustules) with <3 nodules • >12 non-inflammatory lesions (comedones). • informed consent obtained. Exclusion Criteria • concurrent intake or use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids. • concurrent application or use within 2 weeks of baseline of topical acne or rosacea medications or topical anti-inflammatory medication, which may influence study outcome, such as corticosteroids or calcineurin inhibitors. • history of sensitivity or intolerance associated with use of components of medications or products used in the study. • presence of concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments. Efficacy Assessments Lesion Count Reduction • Primary Endpoint: Mean percent inflammatory lesion count reduction at endpoint. • Secondary Endpoints: Mean percent non-inflammatory and total lesion count reduction at endpoint. Investigator Global Assessment (IGA) • Completely Clear No inflammatory lesions present • Near Clear Very few inflammatory lesions present • Marked Clearance Few inflammatory lesions present (~25%) • Moderate Clearance Partial reduction in inflammatory lesions (~40% to 50%) • Minimal Clearance Minimal change observed in inflamma-tory lesions • No Clearance No reduction in inflammatory lesions from baseline • Worsening Increase in inflammatory lesions compared to baseline. Subject Global Assessment (SGA) • Patients rated their endpoint status as completely clear, marked improvement, moderate improvement, minimal improvement, no improvement, or worsening despite treatment. Study Group Characteristics Study group lesion count characteristics and changes are depicted in Table 1.   Assessing Outcomes Therapeutic outcomes based on inflammatory, non-inflammatory, and total lesion count reductions for Group 1 and Group 2 are depicted in Table 2. Investigator Global Assessments (IGA) and Subject Global Assessments (SGA) for week 10 are reported in Table 3.   Adverse Effects and Skin Tolerability No serious adverse events occurred during the study. One female patient on oral minocycline discontinued treatment due to development of dizziness. Two male patients stopped therapy due to gastrointestinal upset associated with oral doxycycline use. Two patients in the group using BP 6% cleanser for facial acne vulgaris reported transient dryness and two patients also reported mild transient erythema, neither of which interfered with continuation of treatment. Summary of Overall Study Results • In this 10-week, investigator-blinded, randomized trial, once daily use of BP 6% cleanser for facial acne vulgaris and BP 9% cleanser for truncal acne vulgaris provided additional therapeutic benefit in patients treated with oral minocycline or doxycycline 100 mg twice daily as compared to oral antibiotic therapy used as monotherapy along with a nontherapeutic skin cleanser. • The addition of a well-formulated BP cleanser to a regimen of oral antibiotic therapy with minocycline or doxycycline produced its predominant impact upon reduction of inflammatory lesions on the face and trunk. • Both brand formulations of BP 6% cleanser and BP 9% cleanser were well tolerated when used once daily for treatment of facial acne vulgaris and truncal acne vulgaris, respectively. • The therapeutic benefit of a well-formulated BP cleanser (Triaz) in the treatment of acne vulgaris of the face and trunk was noted in this observational trial when used in combination with oral minocycline or doxycycline. Previous evaluations have demonstrated the therapeutic benefit of two brand BP cleansers (Triaz, Brevoxyl Creamy Wash) when used in combination with topical clindamycin phosphate 1% foam (Evoclin) for truncal acne vulgaris.3,5   References 1. Shalita AR, Rafal AS, Anderson DN, et al. Compared efficacy and safety of tretinoin 0.1% microsphere gel alone and in combination with benzoyl peroxide 6% cleanser for the treatment of acne vulgaris. Cutis. 2003;72:167-172. 2. Del Rosso JQ. Therapeutic perspectives in dermatology #1: focus on reviews from current literature related to pharmacotherapy. J Am Osteo Coll Dermatol. 2003;1:30-33. 3. Del Rosso JQ. Therapeutic cleansers: keeping it clean. Skin & Aging. 2003;11:83-88. 4. Del Rosso JQ. Pharmacotherapy update: managing truncal acne vulgaris. Skin & Aging. 2005;8:66-71. 5. Del Rosso JQ. Management of truncal acne vulgaris: current perspectives on treatment. Cutis. 2006;77:285-289. Skin & Aging - ISSN: 1096-0120 - Volume 14 - Issue 12 - December 2006 - Pages: 36 - 39