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The Appearance of Facial Foundation Cosmetics Applied After Metronidazole Gel 1%

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The Appearance of Facial Foundation Cosmetics Applied After Metronidazole Gel 1% TherapeuTics for The clinician The Appearance of Facial Foundation Cosmetics Applied After Metronidazole Gel 1% Zoe D. Draelos, MD; Luz E. Colón, MS, CCRC, CCRA; Norman Preston, PhD; Lori A. Johnson, PhD; Ronald W. Gottschalk, MD, FRCPC The purpose of this study was to assess the of rosacea did not increase with use of metro- cosmetic appearance of commonly marketed nidazole gel 1% and the participants’ selected facial cosmetics when used after the applica- cosmetic regimen. At baseline all 28 participants tion of metronidazole gel 1%. An observational, were classified as having moderate erythema. At open-label, single-site study was conducted week 2, 18 (64%) participants were classified as with women (N530) aged 20 to 75 years and having moderate erythema and 10 (36%) mild. At diagnosed with moderate papulopustular rosa- baseline all 28 (100%) participants were classi- cea (investigator global severityCUTIS score of 3). fied as having moderate rosacea according to After cleansing the face with a gentle skin the investigator global severity score. At week 2, cleanser, participants applied metronidazole 10 (36%) participants were classified as mild and gel 1% once daily before applying their usual 18 (64%) moderate. In addition, few participants facial foundation. Two surveys were conducted: reported cutaneous irritation during the study. At (1) investigator assessment of cosmetic appear- week 2, 10 participants had dryness, 2 had itch- ance; and (2) participant assessment of cosmetic ing, 8 had scaling, and 2 had stinging/burning. appearance.Do The investigator Not also evaluated AccordingCopy to surveys completed by the inves- erythema, disease severity, and tolerability at tigator and the participants themselves, most baseline and week 2. Adverse events were col- participants had a good cosmetic appearance lected. The 28 per-protocol (PP) participants with their facial foundation cosmetics that were had a mean age (standard deviation [SD]) of applied after metronidazole gel 1%. The use 54.0 (10.3) years and a mean duration (SD) of of various cosmetic regimens after applica- rosacea of 15.4 (13.2) years. The median response tion of metronidazole gel 1% did not cause score for both the investigator and participant as- rosacea symptoms to worsen and treatment sessments of cosmetic appearance was 10 (best) was well-tolerated. for each survey question. Signs and symptoms Cutis. 2011;87:251-259. osacea is a chronic inflammatory disease of the skin; its etiology remains unknown.1,2 The Dr. Draelos is from Dermatology Consulting Services, High Point, North Carolina. Ms. Colón and Drs. Preston, Johnson, and R proposed mechanisms for this disease can be Gottschalk are from Galderma Laboratories, LP, Fort Worth, Texas. divided into a number of diverse groups including This study and the development of this article were funded by chemicals and ingested agents, climatic exposures, Galderma Laboratories, LP. Dr. Draelos is a researcher for Galderma matrix degeneration, microbial organisms, piloseba- Laboratories, LP. Ms. Colón and Drs. Preston, Johnson, and ceous unit abnormalities, and vasculature.1 The pri- Gottschalk are employees of Galderma Laboratories, LP. The study was registered on April 25, 2008 at www.clinicaltrials.gov mary features of rosacea include transient erythema with the identifier of NCT00668655. (flushing), nontransient erythema, papules, pustules, Correspondence: Lori A. Johnson, PhD ([email protected]). and telangiectases.3-5 Burning, dry appearance, edema, WWW.CUTIS.COM VOLUME 87, MAY 2011 251 Copyright Cutis 2011. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher. Therapeutics for the Clinician ocular and peripheral manifestations, phymatous appearance for the patient. In general, cosmetic changes, and stinging also can be observed. A num- foundations help to provide some level of camouflage ber of risk factors have been associated with rosacea for the underlying red skin.7 The purpose of this including the use of topical corticosteroids, chronic observational study was to determine the cosmetic actinic damage, tendency for flushing, genetic fac- appearance of commonly marketed facial cosmetics tors, and northern or eastern European heritage.1,6,7 In when used after the application of metronidazole addition, several common triggers have been reported gel 1%. in the literature including alcohol, chemical irrita- tion, cosmetics, exposure to extreme temperatures, Methods heavy exercise, humidity, spicy food, stress, sunlight, Study Population—This open-label, single-site study and wind.3,4,8 involved 30 participants.26 Women aged 20 to 75 years The National Rosacea Society estimates that of any race were included if they were diagnosed with more than 16 million individuals in the United moderate rosacea (investigator global severity score States are affected by rosacea. According to the of 3 [classified as moderate erythema with several National Rosacea Society, a recent gallup poll found small or large papules/pustules and up to 2 nodules]), that 78% of Americans are unaware of this disease or willing to stop current rosacea medication for at least its treatment.9 The prevalence of rosacea appears to 2 weeks, willing to use the study-provided cleanser be increasing in the United States, which may be the and not change skin care products or cosmetics dur- result of aging in the baby boom generation.10,11 One ing the study, and in good general health according study (N52933) found that rosacea prevalence was to medical history. Participants were required to 16% in white women in the United States.12 Efforts have an established routine of cosmetic application by the National Rosacea Society have raised aware- of at least 3 months. If they used medications to treat ness of this skin disorder.9 In Europe, it is estimated a concurrent medical condition, the type and dosage that as much as 10% of the population is affected by must have been stable for at least 3 months prior this disease.13,14 The onset of rosacea typically occurs to study entry. All participants read and signed the after the age of 30 years and the disease is more com- approved informed consent form after the nature of mon in women but tends to beCUTIS more severe in men.3,15 the study had been fully explained and prior to any Rosacea is known to adversely affect a patient’s study-related procedures. The study was conducted quality of life.4 It can cause anxiety, embarrassment, in accordance with the ethical principles of the and decreased self-esteem.16 Avoidance of social Declaration of Helsinki, Good Clinical Practice situations also occurs in some cases.17 Professional guidelines, and local regulatory requirements. relationships can be affected and patients have Individuals who were pregnant or breastfeeding even reported losing their jobs.18 In some instances, or planned to become pregnant during the course a correlationDo between rosacea Not and depression can of the study,Copy had known allergies or sensitivities to exist.19 All of the factors underscore the importance ingredients contained in the test products, or failed of medical treatments for this disease that are safe, to undergo a washout period of 14 days for the use of effective, and acceptable for the patient to include topical rosacea therapy were not allowed to partici- in his/her daily skin care routine. Therefore, treat- pate in the study. Individuals were excluded if they ment regimens should be designed to address indi- did not routinely wear facial foundation or if they vidual signs and symptoms as well as disease subtype were unwilling to stop their current rosacea medi- and severity.20 cation for 2 weeks. They were free to discontinue Topical metronidazole has been used for the participation in the study at any time for any reason. treatment of rosacea since the early 1980s.21,22 This Treatment—Each participant was instructed to compound is one of the most effective agents for wash the face with the provided Cetaphil® Gentle improving the lesions of rosacea.4 It is used both Skin Cleanser, rinse, and pat dry. They then were told alone and in combination with other products, such to apply metronidazole gel 1% once daily (morning) as oral antibiotics and anti-inflammatory agents.23,24 and wait 10 minutes for it to dry before applying their Little information currently is available regard- usual facial foundation (no particular foundation was ing the acceptability of metronidazole gel 1% when used), powder, and eye shadow. This regimen contin- used with cosmetic foundations. Rosacea patients are ued for 2 weeks. The first and last doses of metroni- known to experience hypersensitivity to some cosmet- dazole gel 1% and cosmetic applications were applied ics and medications.25 Ideally, rosacea patients should under the supervision of study staff at the study site be able to use their topical medications and then during the baseline visit and the final visit at week 2. apply facial foundation as well as other cosmetic prod- Compliance—The study product was collected ucts as desired. Cosmetics help maintain a favorable and weighed at baseline and week 2 to document 252 CUTIS® WWW.CUTIS.COM Copyright Cutis 2011. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher. Therapeutics for the Clinician treatment compliance. Participants were questioned regarding their use of study medication. Table 1. Cosmetic Appearance—Cosmetic appearance was Summary of Baseline Demographic evaluated in the per-protocol (PP) population, which excluded participants considered not evaluable due Characteristics to major deviations from the study protocol. Partici- Safety/ITT pants self-assessed the cosmetic appearance of their Population PP Population facial foundation when it was applied after metro- nidazole gel 1% treatment. They also maintained a (N530) (N528) diary of their impressions. The investigator assessed Age, y cosmetic appearance at baseline and week 2.
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