Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: Review and clinical practice experience.

Rosacea has been reported less frequently among individuals with skin of color than in those with white skin, but rosacea is not a rare disease in this population. In fact, rosacea might be underreported and underdiagnosed in populations with skin of color because of the difficulty of discerning erythema and telangiectasia in dark skin. The susceptibility of persons with highly pigmented skin to dermatologic conditions like rosacea, whose triggers include sun exposure, is probably underestimated. Many people with skin of color who have rosacea might experience delayed diagnosis, leading to inappropriate or inadequate treatment; greater morbidity; and uncontrolled, progressive disease with disfiguring manifestations, including phymatous rosacea. In this article, we review the epidemiology of rosacea in skin of color and highlight variations in the clinical presentation of rosacea across the diverse spectrum of patient populations affected. We present strategies to aid in the timely diagnosis and effective treatment of rosacea in patients with skin of color, with an aim of promoting increased awareness of rosacea in these patients and reducing disparities in the management of their disease.

Dermatological Concerns in the Latino Population

The Latino, or Hispanics in the United States, are the drivers behind demographic growth. They are heterogeneous in many dimensions related to health risks and dermatological conditions. Understanding the heterogeneity and clinical manifestation of skin concerns in such population is essential for health care providers.

Hyperpigmentation Disorders in Hispanic Population in the United States

The Hispanic population is the third largest growing group in the United States and is projected to increase to 119 million by 2060. Skin of color populations including Hispanics are more susceptible to a variety of pigmentary disorders including melasma and post-inflammatory hyperpigmentation (PIH). Most previous treatment options for these disorders remain unsatisfactory. Current treatment options include topical therapies using skin lightening/bleaching agents, chemical peels, and physical therapies such as microdermabrasion, microneedling, radiofrequency, and lasers. Combination therapies using skin lighting agents, peels, and physical means are also commonly used. New trends include protection and prevention using sunscreens, physical blockers, and the use of new and effective anti-oxidants and anti-inflammatory agents. The choice of therapeutic agents involves assessment of the risk-benefit profile of each individual. As the pathophysiology of melasma and PIH are being intensely investigated and studied, the treatment options are also expanding. In this review, the current therapeutic options are summarized and new and emerging treatment options for PIH and melasma are discussed. J Drugs Dermatol. 2019;18(3 Suppl):s112-114.

Hyperpigmentation Disorders in Hispanic Population in the United States

The Hispanic population is the third largest growing group in the United States and is projected to increase to 119 million by 2060. Skin of color populations including Hispanics are more susceptible to a variety of pigmentary disorders including melasma and post-inflammatory hyperpigmentation (PIH). Most previous treatment options for these disorders remain unsatisfactory. Current treatment options include topical therapies using skin lightening/bleaching agents, chemical peels, and physical therapies such as microdermabrasion, microneedling, radiofrequency, and lasers. Combination therapies using skin lighting agents, peels, and physical means are also commonly used. New trends include protection and prevention using sunscreens, physical blockers, and the use of new and effective anti-oxidants and anti-inflammatory agents. The choice of therapeutic agents involves assessment of the risk-benefit profile of each individual. As the pathophysiology of melasma and PIH are being intensely investigated and studied, the treatment options are also expanding. In this review, the current therapeutic options are summarized and new and emerging treatment options for PIH and melasma are discussed. J Drugs Dermatol. 2019;18(3 Suppl):s112-114.

Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials

Dupilumab, a monoclonal antibody that blocks the shared receptor subunit for interleukin (IL)-4 and IL-13, is currently approved for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD). The efficacy and safety of dupilumab for AD among racial subgroups is unknown. This post hoc analysis from three phase 3 trials assessed the efficacy and safety of dupilumab vs placebo by racial subgroup (White, Asian, Black/African American). Data from LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02277769), and CHRONOS (NCT02260986) were pooled. Outcomes included mean and percent change from baseline to week 16 in the key therapeutic domains Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (NRS), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure, as well as Investigator's Global Assessment and pain or discomfort assessed by the European Quality of Life-5 Dimensions 3 level questionnaire. A total of 2,058 patients (White n=1,429, Asian n=501, Black/African American n=128) were included in the current analysis. Baseline demographics and disease characteristics were balanced between treatment groups and racial subgroups. In the three trials, dupilumab significantly (P<0.0001) improved all assessed outcomes compared with placebo in the White and Asian subgroups. In the smaller Black/African American subgroup, dupilumab significantly (P<0.0001) improved EASI endpoints and mean changes in Peak Pruritus NRS and DLQI vs placebo, with positive numeric trends favoring dupilumab in all other endpoints. Dupilumab was generally well tolerated, with an acceptable safety profile in all racial subgroups. Serious adverse events occurred more frequently with placebo; treatment discontinuations due to adverse events were rare in all treatment groups. Significant clinical improvement and a favorable benefit-risk profile can be achieved with dupilumab treatment in patients of White, Asian, and Black/African American racial subgroups with moderate-to-severe AD inadequately controlled with topical medications. ClinicalTrials.gov identifiers: NCT02277743, NCT02277769, NCT02260986

Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin.

INTRODUCTION: Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV. METHODS: This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], weeks 4, 8, and 12), percent reduction in lesions (weeks 4, 8, and 12), and subject questionnaires (week 12). Safety assessments included adverse events (AEs) and tolerability. RESULTS: Mean IL counts were significantly reduced from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates. CONCLUSION: 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000

J Drugs Dermatol. 2018;17(3):264-273.

Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials.

BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

Investigator-Blinded, Single-Center Study to Evaluate the Efficacy and Tolerability of a 4% Hydroquinone Skin Care System Plus 0.02% Tretinoin Cream in Mild-to-Moderate Melasma and Photodamage.

OBJECTIVE: To evaluate the treatment of mild-to-moderate epidermal melasma and photodamage using a 4% hydroquinone skin care system plus tretinoin 0.02% cream. METHODS: Single-center, investigator-blinded study in 39 adult females with mild-to-moderate epidermal melasma, mild-to-marked pigmentation intensity, and Fitzpatrick skin type III to VI treated for 24 weeks. Improvements in melasma severity, pigmentation intensity, photodamage, and patient satisfaction were assessed at weeks 4, 8, 12, 18, and 24. Cutaneous tolerability was assessed by investigator (erythema, dryness, peeling) and patients (burning and stinging). Adverse events (AEs) were monitored throughout. RESULTS: Melasma severity, pigmentation intensity, and melasma area and severity index (MASI) scores relative to baseline were all significantly reduced from week 4 onward (P<.001). In addition, signs of facial photodamage were significantly improved. At week 24, 87.9% of patients were "satisfied" or "very satisfied" with the overall treatment effectiveness and Quality of Life (QoL) was much improved. No patient discontinued due to lack of efficacy or treatment-related AEs. One patient (2.8%) reported severe cutaneous intolerability (erythema at week 4). CONCLUSION: Treating mild-to-moderate melasma using a 4% hydroquinone skin care system plus 0.02% tretinoin cream can significantly reduce the severity and intensity of melasma and associated pigmentation, and improve signs of photodamage within four weeks. Treatment was generally well tolerated and associated with high levels of patient satisfaction.

Clinical Evaluation of a 4% Hydroquinone + 1% Retinol Treatment Regimen for Improving Melasma and Photodamage in Fitzpatrick Skin Types III-VI.

The bene ts of monotherapy with hydroquinone for melasma and retinoids for photodamaged skin is well established. Here we report results of a hydroquinone skincare regimen designed for melasma treatment combined with a cosmetic retinol cream on subjects presenting with both melasma and facial photodamage in a 24-week study. Improvement in melasma and photodamage ef cacy pa- rameters of melasma pigmentation intensity and melasma area and severity index (MASI), as well as overall photodamage and mottled hyperpigmentation were found by week 4, the rst post-baseline time point. By week 8 signi cant improvements were also found in melasma disease severity assessment, tactile roughness, ne wrinkles, crepiness, actinic lentigines, and laxity. By week 18 signi cant reduction in coarse wrinkles was evident. Bene ts persisted through the study end on the panel of 31 subjects, with over 3/4 of par- ticipants demonstrating improvements in 10 of the 11 graded attributes. For the remaining attribute, coarse wrinkling, approximately 50% of the panel showed improvement. The regimen produced an average of "marked improvement" in melasma severity (51-75% improvement). Results of tolerance evaluations documented overall treatment mildness for a majority of the study participants. Subject questionnaires concur with high ratings of the study regimen for tolerability, ef cacy perception, product aesthetics and overall treat- ment satisfaction in subjects of Fitzpatrick Skin Type III-VI classi cation with melasma and photodamage in mild-to-moderate severity. J Drugs Dermatol. 2016;15(11):1435-1441..

Reliability assessment and validation of the Melasma Area and Severity Index (MASI) and a new modified MASI scoring method.

BACKGROUND: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. OBJECTIVE: We sought to determine the reliability and validity of the MASI. METHODS: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. RESULTS: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. LIMITATIONS: Patients were limited to Hispanic, African, and Asian backgrounds. CONCLUSION: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

The effects of a high glycerin content hydrogel premolded mask dressing on post-laser resurfacing wounds.

BACKGROUND: Laser resurfacing for the rejuvenation of facial skin remains a popular cosmetic procedure. Postoperative care for laser resurfacing is important to optimize healing, reduce pain and minimize complications. OBJECTIVE: To compare the efficacy of the new dressing against placebo (Vaseline® cream) after Er:YAG laser resurfacing. METHODS: Fifteen patients between 45 and 72 years of age with facial wrinkles were enrolled in the study. Patients underwent full-face Er:YAG procedures. The wounds were then dressed: one side of the face was treated with Vaseline and the other with a hydrogel dressing. Erythema, edema, pigmentation, average time of re-epithelization, pain score, itching, clinical evaluation of infection, crust formation and acidity were documented. RESULTS: The hydrogel dressing decreased postoperative morbidity. The site treated by hydrogel showed a shorter epithelial healing time than the Vaseline site. The dressing relieved the immediate pain of facial resurfacing as well as preventing crust formation and itching. CONCLUSION: A hydrogel dressing is a better and suitable alternative to the open technique to manage post-laser wound healing.

Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus. OBJECTIVE: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE). METHODS: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report. RESULTS: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles. CONCLUSIONS: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles.

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device. OBJECTIVE: We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles. METHODS: In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms. RESULTS: Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13. LIMITATIONS: Mostly white women and subjects with Fitzpatrick skin types II and III were included. CONCLUSION: Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.

Treatment of the aged hand with injectable poly-l-lactic acid.

We report the use of injectable poly-l-lactic acid (PLLA) for volume restoration in a 45-year-old white female who was concerned about the appearance of her hands. The patient expressed a desire for long-term restoration, and selected injectable PLLA because of its known 2-year duration of effect, although she was informed that injectable PLLA is not FDA-approved for use in the hands. After reconstitution with 8 ml of diluent plus lidocaine, 0.1-0.2-ml aliquots of injectable PLLA were injected into selected sites, up to 5 ml per hand. The patient underwent three identical treatments, followed by postinjection use of moisturizing cream and massage; improvement in appearance was noted by the patient between the second and third treatments. Correction was maintained for at least 18 months, with no adverse events. We have also briefly reviewed the literature on the use of injectable PLLA for volume restoration in the hand.

Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.

Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris. The primary efficacy endpoint was the change from baseline in total acne lesions; the primary safety endpoint was the change in cutaneous irritation scores. The 247 participants (mean age: 18.5 years) were randomized to either the morning/morning regimen (n = 123) or the morning/evening regimen (n = 124). The morning/morning regimen was determined to be non-inferior to the morning/evening regimen in reduction of total acne lesions. The tolerability of both regimens was comparable. The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris.

Clinical role and application of superficial chemical peels in today's practice.

Chemical peeling is a popular, relatively inexpensive, and generally safe method to refresh and rejuvenate skin. This review focuses on superficial chemical peels and their use in routine clinical practice. A wide variety of peels are available, utilizing various actives and concentrations, including a recently introduced salicylic acid derivative, beta-lipohydroxy acid, which has properties that may expand the clinical use of peels. Superficial peels can be used to enhance treatment within a variety of conditions, including acne, melasma, dyschromias, photodamage and actinic keratoses. In addition, peels can be combined with other in-office procedures to optimize outcomes and enhance patient satisfaction, and allow clinicians to tailor the treatment to individual patient's needs. Successful outcomes are based on a thorough understanding and application of correct chemical peel procedures, including history-taking, pretreatment, preparation, peel selection, patient communication and maintenance regimens.Used properly, the superficial chemical peel has the potential to fill an important therapeutic need in the treatment armamentarium of dermatologists and plastic surgeons.

Poly-L-lactic acid for the treatment of trauma-induced facial lipoatrophy and asymmetry.

Poly-L-lactic acid (PLLA) is approved by the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus (HIV)-associated lipoatrophy. Over the past several years, PLLA has been increasingly used as a treatment for lipoatrophy secondary to the natural process of aging. There have been no reports on the use of PLLA for trauma-induced facial lipoatrophy and asymmetry. In this article, we review the safety, effectiveness, treatment guidelines, mechanism of action, and quality-of-life (QOL) impact of PLLA. We present a patient with facial lipoatrophy and asymmetry secondary to injury from a motor vehicle accident that was effectively treated using PLLA. The future role of PLLA in the treatment of trauma-induced facial lipoatrophy and asymmetry, as well as other disorders, also is discussed.

Mequinol 2%/tretinoin 0.01% topical solution for the treatment of melasma in men: a case series and review of the literature.

Melasma is a common hyperpigmentation disorder that typically affects women, though up to 10% of white individuals seeking treatment for melasma are men. Melasma can be a source of embarrassment for men because of its association with women and pregnancy. We performed a case series assessing the use of mequinol 2%/ tretinoin 0.01% topical solution in 5 men with melasma. Four of 5 patients achieved complete clearance of melasma at 12 weeks, and 1 patient showed moderate improvement. Side effects were minimal and consisted of stinging in one patient. All patients maintained results at the 16-week follow-up visit. Mequinol 2%/tretinoin 0.01% topical solution was an effective and well-tolerated treatment of melasma in men. The vehicle resulted in good compliance and minimal adverse effects in patients. This is the first report describing the use of mequinol 2%/tretinoin 0.01% topical solution for the treatment of melasma in men; there are no reports in women.

Successful treatment of moderate to severe melasma with triple-combination cream and glycolic acid peels: a pilot study.

Triple-combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%, and currently is the only US Food and Drug Administration-approved drug for the topical treatment of melasma. Furthermore, it is the only US Food and Drug Administration-approved product containing hydroquinone. Anecdotal evidence suggests that improvements in melasma can be achieved with a multifactor approach involving TC cream with a variety of procedures. A pilot study was designed to evaluate the efficacy and safety of sequential treatment with TC cream and a series of glycolic acid (GA) peels in participants with moderate to severe melasma. Participants were treated with TC cream for 2 weeks before the alternating sequential treatment cycles with TC cream and GA peels began. A total of six 2-week cycles of TC cream and 5 GA peels were used. Efficacy and safety evaluations were conducted at weeks 6 and 12. Investigator global assessment (IGA) ratings indicated that 1 of 20 participants (5%) had achieved treatment success (clear/almost clear) as early as week 6 and most participants had achieved treatment success by week 12 (65% [13/20]; P < .001 vs baseline). Objective absorption spectrometry measurements of the difference in melanin for involved versus uninvolved skin confirmed that hyperpigmentation was significantly reduced in participants at weeks 6 and 12 compared with baseline (P < .001 for both). Investigator and participant evaluations revealed that most participants (> or = 90%) showed improvement (excellent improvement, much improved, improved) by week 12 with alternating sequential treatment with TC cream and GA peels. Furthermore, the results of this study indicated that sequential treatment with TC cream and GA peels was well-tolerated.

Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea.

BACKGROUND: Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea. OBJECTIVE: To evaluate the efficacy and safety of once-daily anti-inflammatory dose doxycycline for the treatment of rosacea. METHODS: In two phase III, parallel-group, multicenter, randomized, double-blind, placebo-controlled studies (studies 301 and 302), patients received 40-mg of controlled-release doxycycline (n = 269) or placebo (n = 268) for 16 weeks. The primary efficacy end point was the mean change from baseline in facial inflammatory lesion count. RESULTS: The mean lesion count at baseline was approximately 20 in each study arm. At week 16, the mean change from baseline in lesion count in the active-treatment groups was -11.8 in study 301 and -9.5 in study 302 compared with -5.9 and -4.3, respectively, in the placebo groups (P < .001 for both comparisons). Anti-inflammatory dose doxycycline was well tolerated; the most common adverse events were nasopharyngitis (4.8%), diarrhea (4.4%), and headache (4.4%). LIMITATIONS: In both studies, the reduction of inflammatory lesion counts did not plateau within the 16-week time frame in either treatment group. Rosacea is often treated for a period of months or years. The duration of the studies did not allow for assessment of safety beyond 16 weeks or whether the progressive improvement seen with active treatment would continue beyond 16 weeks. Neither study assessed the effect of treatment in patients with only erythematotelangiectatic (subtype 1) rosacea. CONCLUSION: Once-daily anti-inflammatory dose doxycycline appears to be effective and safe for the treatment of rosacea.