Rosacea, also known as acne rosacea, is a chronic, inflammatory skin condition. Active rosacea is characterized by episodic erythema, edema, papules, and pustules that occur primarily on the face but may also be present on the scalp, ears, neck, chest, and back. If left untreated, rosacea can lead to persistent erythema, telangiectasias, and rhinophyma (hyperplasia and nodular swelling and congestion of the skin of the nose). The etiology and pathogenesis of rosacea are unknown, but may be due to both genetic and environmental factors.
While rosacea cannot be eliminated, treatment can be effective to relieve its signs and symptoms. Treatments include pharmacologic agents, such as oral and topical antibiotics, topical retinoids, isotretinoin, clonidine, beta-blockers, and anti-inflammatories, as well as self-care measures, including avoidance of skin irritants and dietary items thought to exacerbate acute flare-ups. Other techniques have been used to reduce visible blood vessels, treat rhinophyma, reduce redness, and improve appearance. These include laser and light therapy, dermabrasion, chemical peels, surgical debulking, and electrosurgery.
A number of laser and focused light devices have received marketing clearance for the treatment of rosacea via the U.S. Food and Drug Administration’s (FDA’s) 510(k) process. These include the Candela pulse dye laser system, the Lumenis One Family of Systems intense pulsed light component, and the Harmony XL multiapplication platform laser. Other laser and light devices are also used off-label for treatment of active rosacea or related cosmetic effects. These include lasers that emit light at 1320 nm (Candela Smoothbeam™ and CoolTouch®); intense pulsed light systems, which emit light in the range of 590 to 1200 nm (Radiancy ClearTouch™, MED flash II and Ellispse I2PL); and lasers or high-intensity light devices, which emit violet or blue (around 414 nm) and red (around 633 nm) light (Aura™, Clearlight and Dermillume).
Nonpharmacologic treatment of rosacea, including but not limited to laser and light therapy, dermabrasion, chemical peels, surgical debulking and electrosurgery, is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating its impact on improved health outcomes.
The following treatments are considered cosmetic when used to treat the COSMETIC effects associated with rosacea such as erythema, telangiectasias, and facial scarring:
No additional statements.
Summary of Evidence
For individuals who have rosacea who receive nonpharmacologic treatment (e.g., laser therapy, light therapy, dermabrasion), the evidence includes systematic reviews and several small, randomized, split-face design trials. The systematic reviews report favorable effects on erythema and telangiectasia with several laser types, including intense pulsed light (IPL), pulsed dye lasers, and neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers. Overall, the systematic review results were insufficient to establish whether any laser type is more effective and safer than others. The randomized controlled trials (RCTs) evaluated laser and light therapy. One RCT compared combination laser and pharmacologic therapy with pharmacologic therapy alone and 2 RCTs compared combination laser and pharmacologic therapy with laser therapy alone, but the lack of an arm evaluating laser therapy alone against established pharmacologic therapy does not allow a direct assessment on the efficacy of laser or light treatment compared with alternative treatments. No trials assessing other nonpharmacologic treatments were identified. There is a need for RCTs that compare nonpharmacologic treatments with placebo controls and with pharmacologic treatments.
Rationale
Martignago at al (2024) conducted a systematic review on the efficacy and safety of intense pulsed light for the treatment of rosacea. Fourteen studies qualified for final analysis and included patients with Fitzpatrick skin types I to IV, with ages ranging from 15 to 78 years. Although the included studies showed heterogeneity between the parameters used, most studies demonstrated positive effects of IPL treatment on telangiectasia and erythema in rosacea and that the adverse effects presented were transitory. Methodological quality of the studies was poor, and although most studies showed the efficacy of intense pulsed light in the treatment of rosacea, the poor quality of the studies was of concern.
Husein-ElAhmed et al (2022) published a meta-analysis comparing the efficacy and tolerability of pulsed dye laser to other laser and light therapies. Both randomized and non-randomized studies were considered for inclusion; background erythema, telangiectasias, pain, and treatment success were analyzed. The studies did not compare interventions with pharmacologic treatments or placebo controls, only pulsed dye laser to other laser and light therapies. 12 relevant studies were assessed. Erythema (RR:0.38 95%CI: -0.20-0.95), telangiectasias (RR:0.54 95%CI: -0.87-1.94), and the treatment success throughout the physician's assessment (RR:1.23 95%CI: 0.74-2.04) and the patient's satisfaction (RR:1.15 95%CI: 0.73-1.82) were not significantly different between pulsed dye laser and other laser and light-based therapies (LLBT). In the pain domain, PDL was as painful as other LLBT (RR:-0.23 95%CI: -0.96-0.49) but more painful than neodymium: yttrium-aluminum-garnet laser (RR:0.84 95%CI: 0.53-1.14) and less than intense pulsed light (RR:-1.18 95%CI: -1.56-0.80). Researchers concluded that the quality of the evidence to support any recommendation on LLBT in rosacea is low-to-moderate. Among all the available devices, PDL holds the most robust evidence, although in the meta-analysis the effectiveness was comparable to other LLBT.
A Cochrane systematic review by van Zuuren et al (2015) assessed 106 studies, comprising 13,631 participants, the majority with papulopustular rosacea, followed by erythematotelangiectatic rosacea. Topical interventions included metronidazole, azelaic acid, ivermectin, brimonidine or other topical treatments. Systemic interventions included oral antibiotics, combinations with topical treatments or other systemic treatments, i.e. isotretinoin, and several studies evaluated laser or light-based treatment. Quality of the evidence was moderate to high for most outcomes, but for some low to very low. The same authors updated this review in 2019, with a focus on rosacea phenotypes. The 2019 study identified only 7 trials on light and/or laser therapy, and the trials did not compare these interventions with pharmacologic treatments or placebo controls, although 2 studies evaluated laser therapy in combination with pharmacologic therapy. Trial findings on light and/or laser therapy were considered low-quality and were not pooled. The remainder of the RCTs in the review evaluated pharmacologic treatments.
Tong et al (2022), in a randomized clinical trial, reported greater improvement in erythema with broadband light (BBL) (intense pulsed light) plus intradermal botulinum toxin (BTX) compared to broadband light alone. The single-blind, split-face controlled study included 22 patients with erythemato telandiectasia. Patient cheeks were randomly divided into experimental group and control group, and treated 3 times with an interval of one month. The experimental group received BBL treatment and intradermal injection of BTX, and the control group received BBL treatment and intradermal injection of the same amount of normal saline. In the second and third treatments both groups received the same BBL treatment. Compared with the control group, the hydration in the experimental group increased and the global flushing symptom score (GFSS), VISIA red value, erythema index, transepidermal water loss, and sebum secretion decreased. The differences were statistically significant (p < 0.05). In the experimental group, at 3 months after the first treatment, compared with before treatment, the GFSS, VISIA red value, erythema index, transepidermal water loss and sebum secretion decreased the hydration increased. Investigators concluded that BTX intradermal injection combined with BBL has a definite therapeutic effect on the improvement of rosacea related erythema and flushing, which is better than simple BBL, and has high safety.
Several randomized trials evaluating nonpharmacologic treatment for rosacea, all of which used split-faced designs have been undertaken. Most compared 2 types of lasers, and none used a placebo control or a pharmacologic treatment as a comparator. Additional RCTs were identified that evaluated the combination of nonpharmacologic and pharmacologic treatments against nonpharmacologic or pharmacologic treatment alone. No randomized controlled trials evaluating dermabrasion, chemical peels, surgical debulking, or electrosurgery for treating rosacea were identified. Most studies reported a significant difference in erythema compared to baseline with laser treatments, but no studies found significant differences between laser modalities. For telangiectasia, significant improvements were observed with laser treatments, but only the study by Karsai et al (2008) reported a significant difference between laser modalities in favor of dual wavelength compared to single wavelength. In a trial by Campos et al (2019), the primary outcome of change in Dermatology Life Quality Index was significant compared to baseline after the first (p<.001), second (p=.018), and third (p=.001) treatments. Three studies (Alam, Maxwell, Neuhaus) reported positive findings in subjective measures of patient satisfaction, including patient assessment of change in erythema. Adverse effects in these studies were mild and transient overall. One study (Alam) reported a significant difference in pain, which was in favor of pulsed dye laser compared to neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers. An RCT by Sodha et al (2021), involved 34 patients in a two-arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients had moderate to severe clinical erythema, and reported similar improvements in erythema with pulsed dye laser with topical oxymetazoline compared to topical oxymetazoline alone.
Professional guidelines
In 2014, the American Acne and Rosacea Society issued consensus recommendations on the management of rosacea. The Society stated that lasers and intense pulsed light (IPL) devices could improve certain clinical manifestations of rosacea that have not responded to medical therapy. The recommendations indicated that these therapies would have to be repeated intermittently to sustain improvement.
In 2017, the Rosacea Consensus panel, comprised of international experts including representatives from the U.S., published recommendations for rosacea treatment. The panel agreed that treatments should be based on phenotype. IPL and pulsed dye laser were recommended for persistent erythema, but not for transient erythema. IPL and lasers were also recommended for telangiectasia rosacea. The panel updated their recommendations on rosacea treatment in 2019, agreeing that lasers were recommended for persistent centrofacial erythema. They also noted that “use of IPL and vascular lasers in darker skin phototypes requires consideration by a healthcare provider with experience…, as it can result in dyspigmentation.” The panel also acknowledged that combining treatments could benefit patients with more severe rosacea and multiple rosacea features; however “there remains an ongoing need for more studies to support combination treatment use in rosacea.”
In 2019, the National Rosacea Society Executive Committee published an expert consensus document on management options for rosacea. This document endorses treatment goals of an Investigator Global Assessment score of 0 and normalization of skin tone and color due to the notable impact of rosacea on patient quality of life. Light devices are discussed as treatment options along with medications, skin care, and lifestyle interventions. Based on weak evidence, IPL, pulsed dye lasers, and potassium titanyl phosphate lasers are listed as moderately effective treatment options for persistent erythema, particularly due to telangiectasia.
Reference List
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Acknowledgements:
CPT® codes copyright American Medical Association® 2023. All rights reserved.
CDT codes copyright American Dental Association® 2023. All rights reserved.
