Description:
Rosacea is a chronic, inflammatory skin condition without a known cure; the goal of treatment is symptom management. Nonpharmacologic treatments, including laser and light therapy, as well as dermabrasion, are proposed for patients who do not want to use or are unresponsive to pharmacologic therapy.

For individuals who have rosacea who receive nonpharmacologic treatment (e.g., laser therapy, light therapy, dermabrasion), the evidence includes several small randomized, split-face design trials. Relevant outcomes are symptoms, change in disease status and treatment-related morbidity. None of the randomized controlled trials (RCTs) included a comparison group of patients receiving a placebo or pharmacologic treatment; therefore, these trials do not offer definitive evidence on the efficacy of nonpharmacologic treatment compared with alternative treatments. There is a need for RCTs that compare nonpharmacologic treatments with placebo controls and with pharmacologic treatments. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background
Rosacea
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. On occasion, rosacea may affect the eyes. Patients with rosacea tend to flush or blush easily. Because rosacea causes facial swelling and redness, it is easily confused with other skin conditions, such as acne, skin allergy, and sunburn.

Rosacea mostly affects adults with fair skin between the ages of 20 and 60 years and is more common in women, but often most severe in men. Rosacea is not life-threatening, but if not treated, may 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 areunknown but may result from both genetic and environmental factors. Some theories on the causes of rosacea include blood vessel disorders, chronic Helicobacter pylori infection, demodex folliculorum (mites), and immune system disorders.

While the clinical manifestations of rosacea do not usually impact the physical health status of the patient, psychological consequences from the most visually apparent symptoms (i.e., erythema, papules, pustules, telangiectasias) may impact the quality of life. Rhinophyma, an end-stage of chronic acne, has been associated with obstruction of nasal passages and basal cell carcinoma in rare, severe cases. The probability of developing nasal obstruction or basal or squamous cell carcinoma with rosacea is not sufficient to warrant preventive removal of rhinophymatous tissue.

Treatment 
Rosacea treatment can be effective in relieving signs and symptoms. Treatment may include oral and topical antibiotics, isotretinoin, β-blockers, clonidine, and anti-inflammatories. Patients are also instructed on various self-care measures such as avoiding skin irritants and dietary items thought to exacerbate acute flare-ups.

Nonpharmacologic therapy has also been tried in patients who cannot tolerate or do not want to use pharmacologic treatments. To reduce visible blood vessels, treat rhinophyma, reduce redness, and improve appearance, various techniques have been used such as laser and light therapy, dermabrasion, chemical peels, surgical debulking, and electrosurgery. Various lasers used include low-powered electrical devices and vascular light lasers to remove telangiectasias, co₂ lasers to remove unwanted tissue from rhinophyma and reshape the nose and intense pulsed lights that generate multiple wavelengths to treat a broader spectrum of tissue.

Regulatory Status
Several laser and light therapy systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for various dermatologic indications, including rosacea. For example, rosacea is among the indications for:

• Candela^® pulse dye laser system (Candela, Wayland, MA)
• Lumenis^® One Family of Systems IPL component (Lumenis, Santa Clara, CA)
• Harmony^® XL multi-application platform laser device (Alma Lasers, Israel)
• UV-300 Pulsed Light Therapy System (New Star Lasers, Roseville, CA)
• CoolTouch^® PRIMA Pulsed Light Therapy System (New Star Lasers, Roseville, CA).

FDA product code: GEX.

Related Policies
20147 Light Therapy for Psoriasis
20186 Light Therapy for Vitiligo
80116 Chemical Peels

Policy:
Non-pharmacologic treatment of rosacea, including, but not limited to, laser and light therapy, dermabrasion, chemical peels, surgical debulking and electrosurgery, is investigational and/or unproven and is therefore considered NOT MEDICALLY NECESSARY.

Benefit Application
BlueCard/National Account Issues
Some state or federal mandates (e.g., FEP) prohibit Plans from denying technologies approved by the U.S. Food and Drug Administration (FDA) as investigational. In these instances, Plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.

Rationale 
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Nonpharmacologic Treatment of Rosacea
Clinical Context and Therapy Purpose
The purpose of nonpharmacologic treatments is to provide a treatment option in patients who have rosacea and do not want to use or are unresponsive to pharmacologic therapies.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with rosacea. Rosacea is characterized by episodic erythema, edema, papules and pustules, and telangiectasia that occur primarily on the face. Clinical presentation varies in individual patients.

Interventions
The therapies being considered are nonpharmacologic treatments. Nonpharmacologic treatment options include laser and light therapy, dermabrasion, chemical peels, surgical debulking, and electrosurgery. Laser and light therapies are typically used for persistent erythema or telangiectasia. During laser and light therapy, light energy is absorbed by hemoglobin in cutaneous vessels, which leads to vessel heating and coagulation. Lasers vary from low-powered electrical devices and vascular light lasers (for telangiectasias removal) to carbon dioxide lasers and intense pulsed lights that generate multiple wavelengths to treat a broader spectrum of tissue.

Frequency and duration of laser and light therapy sessions vary, from once to twice per month, for several months. Because light-based techniques do not cure rosacea, periodic treatments may be necessary to maintain symptom relief.

Comparators
The comparators of interest are pharmacologic therapies, which include oral and topical antibiotics, isotretinoin, β-blockers, alpha2-adrenergic agonists (e.g., oxymetazoline, clonidine), and anti-inflammatories. The selection of a pharmacological agent is dependent on the clinical features present for an individual patient (e.g., redness, edema, papules and pustules).

Outcomes
The general outcome of interest is symptom reduction, which may include a change in redness of skin color or change in erythema score or telangiectasia score. Other outcomes of interest include a reduction in pain, subject satisfaction, and improvement in the quality of life.

Outcome measures can be assessed on treatment completion. Because laser and light therapy are not curative, outcomes can be measured months after treatment to assess symptom recurrence.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse effects, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
A meta-analysis by Chang and Chang (2022) compared the efficacy of pulsed dye laser to intense pulsed light.¹ Only RCTs comparing these 2 modalities were included, and erythema was the only outcome analyzed in meta-analysis.

A meta-analysis by Husein-ElAhmed and Steinhoff (2021) compared the efficacy and tolerability of pulsed dye laser to other laser and light therapies.² 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.

A Cochrane systematic review by van Zuuren et al. (2015) assessed various interventions for rosacea.³; the same authors updated their systematic review in 2019 with a focus on rosacea phenotypes⁴. In 2019, the authors 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.

Wat et al. (2014) identified 9 studies on the efficacy of intense pulsed light (IPL) for treating rosacea.⁵ Two studies were controlled (left-right comparisons), and the remainder were uncontrolled, including a case report.

The systematic reviews by van Zuuren et al. (2019) and Wat et al. (2014) did not pool study findings on the nonpharmacologic treatment of rosacea. Findings of the published systematic reviews highlight the shortage of RCTs on light and laser therapy for treating rosacea. Table 1 compares the studies included in the systematic reviews. Tables 2 and 3 summarize the characteristics and results of the reviews, respectively.

Table 1. Comparison of Trials/Studies Included in Systematic Reviews of Nonpharmacologic Treatment of Rosacea

^a Study evaluated lasers in combination with other therapies. They are listed for completeness but are not included in the results table below.

Table 2. Systematic Review and Meta-Analysis Characteristics

IPL: intense pulsed laser; OL: open-label; RCT: randomized controlled trial.

Table 3. Systematic Review & Meta-Analysis Results

CI: confidence interval; IPL: intense pulsed light; Nd:YAG: neodymium-doped yttrium aluminum garnet; NR: not reported; OR, odds ratio; RR: relative risk; SMD: standard mean difference.

Randomized Controlled Trials
Several randomized trials evaluating nonpharmacologic treatment for rosacea, all of which used split-faced designs, were identified. ^{20,30,12,10,27,28,29,31,32} Most compared 2 types of lasers, and none used a placebo control or a pharmacologic treatment as a comparator. Additional RCTswere identified that evaluated the combination of nonpharmacologic and pharmacologic treatments against nonpharmacologic or pharmacologic treatment alone.^33,34,35,36 No RCTs 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.¹⁰ In the RCT 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.²⁷ Three studies reported positive findings in subjective measures of patient satisfaction, including patient assessment of change in erythema.^20,30,12 Adverse effects in these studies were mild and transient overall. One study reported a significant difference in pain, which was in favor of pulsed dye laser compared to neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers.²⁰ One RCT reported similar improvements in erythema with pulsed dye laser with topical oxymetazoline compared to topical oxymetazoline alone.³³ A more recent RCT reported greater improvement in erythema with broadband light (intense pulsed light) plus intradermal botulinum toxin compared to broadband light alone.35,A summary of key RCT characteristics and results is presented in Tables 4 and 5, respectively. Tables 6 and 7 provide an overview of the relevance and study design/conduct limitations of these RCTs.

Table 4. Summary of Key Randomized Controlled Trial Characteristics

ALA-PDT: 5-aminolevulinic acid photodynamic therapy; IPL: intense pulsed light; Nd:YAG: neodymium-doped yttrium aluminum garnet; NR: not reported.
^a plit face design, yielding an equal number of patients in each treatment group.

Table 5. Summary of Key Randomized Controlled Trial Results/Outcomes

ALA-PDT: 5-aminolevulinic acid photodynamic therapy; CI: confidence interval; IPL: intense pulsed laser; NR: not reported; NS: not significant.

Table 6. Study Relevance Limitations

ALA-PDT: 5-aminolevulinic acid photodynamic therapy
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Clinical context for treatment is unclear; 3. Study population unclear; 4. Study population not representative of intended use; 5. Study population is subpopulation of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not established and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported.
^e Follow-up key: 1. Not sufficient duration for benefits; 2. Not sufficient duration for harms.

Table 7. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Follow-up key: 1. High loss to follow up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Test is not appropriate for outcome type: a) continuous; b) binary; c) time to event; 2. Test is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p-values not reported; 4. Comparative treatment effects not calculated.

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. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. The systematic reviews reported favorable effects on erythema and telangiectasia with several laser types, including IPL, pulsed dye lasers, and Nd: YAG lasers. However, the systematic reviews did not pool results from individual studies and the studies differed in the specific lasers being compared. Overall the systematic review results were insufficient to establish whether any laser type is more effective and safe than others. The 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Acne and Rosacea Society
In 2014, the American Acne and Rosacea Society issued consensus recommendations on the management of rosacea.³⁷ 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 2016, the American Acne and Rosacea Society issued updated consensus recommendations on the management of rosacea.³⁸ The update focused on how medical and device therapies are used — whether concurrently or in a staggered fashion — noting that there is a lack of evidence to justify either use. The Society's consensus recommendation on rosacea management correlated with clinical manifestations observed at the time of presentation is summarized in Table 8:

Table 8. Recommendations on Use of Lasers and Intense Pulsed Light Devices for the Management of Rosacea

IPL: intense pulsed light, YAG: yttrium aluminum garnet; NR: not reported.
^a Grade A: Criteria not described in recommendation; Grade B: Systematic review/meta-analysis of lower-quality clinical trials or studies with limitations and inconsistent findings; lower-quality clinical trial; Grade C:Consensus guidelines; usual practice, expert opinion, case series — limited trial data

Rosacea Consensus Panel
In 2017, the Rosacea Consensus panel, comprised of international experts including representatives from the U.S., published recommendations for rosacea treatment.³⁹ 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.⁴⁰ 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.”

National Rosacea Society
In 2019, the National Rosacea Society Executive Committee published an expert consensus document on management options for rosacea.⁴¹ 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. Both IPL and potassium titanyl phosphate are described as having at least some efficacy for flushing. Nonpharmacologic interventions that are listed as more highly effective treatment options for non-inflamed phymas (based on weak evidence) include carbon dioxide lasers, erbium lasers, cold steel, electrosurgery, and radiofrequency; these same interventions are listed for use in combination with other treatment modalities for inflammatory phymas. Carbon dioxide lasers, erbium lasers, cold steel, electrosurgery, and radiofrequency carry a risk of post-inflammatory hyperpigmentation and should only be provided by appropriately trained individuals.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 9.

Table 9. Summary of Key Trials

NCT: national clinical trial.

References:    

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2. Husein-ElAhmed H, Steinhoff M. Light-based therapies in the management of rosacea: a systematic review with meta-analysis. Int J Dermatol. Feb 2022; 61(2): 216-225. PMID 34089264
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12. Neuhaus IM, Zane LT, Tope WD. Comparative efficacy of nonpurpuragenic pulsed dye laser and intense pulsed light for erythematotelangiectatic rosacea. Dermatol Surg. Jun 2009; 35(6): 920-8. PMID 19397667
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