Montelukast for Atopic Dermatitis
Montelukast should not be used to treat atopic dermatitis, as the most recent and highest-quality evidence demonstrates insufficient data to support its efficacy, and the best available randomized controlled trial shows no benefit over placebo.
Guideline Recommendations
The 2024 American Academy of Dermatology guidelines explicitly state that there are insufficient data at this time to make a recommendation regarding the use of montelukast in the management of atopic dermatitis 1. This represents the current consensus position from the most authoritative dermatology society in the United States.
The 2014 AAD guidelines similarly identified montelukast as lacking adequate evidence for use in atopic dermatitis 1.
Evidence from Clinical Trials
Highest-Quality Evidence Against Use
The most rigorous study examining this question was a randomized, double-blind, placebo-controlled trial published in 2007 that enrolled 60 adults with moderate atopic dermatitis 2. Patients received either montelukast 10 mg daily or placebo for 8 weeks 2.
The results showed no significant differences between montelukast and placebo in any outcome measure 2:
- The improvement in SASSAD score was actually marginally superior in the placebo group (1.76 points) compared to montelukast (1.41 points), with a difference of only 0.35 points (95% CI: -6.1 to 6.8) 2
- No differences were found in investigator or patient assessments of response 2
- No differences in pruritus, sleep disturbance, or topical corticosteroid usage 2
The authors concluded that "the data do not support previous reports of efficacy of montelukast in treatment of atopic dermatitis" 2.
Contradictory Earlier Studies
While some earlier, smaller studies suggested potential benefit, these had significant methodological limitations:
- A 2001 pilot study of only 8 patients showed modest improvement, but this was a very small crossover study with limited generalizability 3
- Another 2001 study compared montelukast to a combined regimen (cetirizine, clarithromycin, topical corticosteroids) and found similar improvements, but this does not establish efficacy since there was no placebo control 4
- A 2009 study specifically demonstrated that montelukast was not effective in treating allergic symptoms outside the airways, including eczema 5
Recommended Treatment Approach Instead
For adults with atopic dermatitis requiring systemic therapy, the evidence-based options include 1:
First-Line Systemic Agents
- Dupilumab (FDA-approved for moderate-to-severe atopic dermatitis, high-certainty evidence) 1
- Tralokinumab (FDA-approved, high-certainty evidence) 1
Second-Line Systemic Agents
- Cyclosporine 3-5 mg/kg/day (off-label in US, limited to 1 year) 1
- Methotrexate 7.5-25 mg weekly 1
- Azathioprine 1.5-2.5 mg/kg/day 1
For Infants and Young Children
- Dupilumab is FDA-approved for infants ≥6 months with moderate-to-severe atopic dermatitis uncontrolled by topical agents, showing 69.7% EASI-75 improvement after 16 weeks 6
- Low-potency topical corticosteroids (hydrocortisone 1%) remain first-line for all ages 6, 7, 8
- Pimecrolimus 1% cream is FDA-approved for infants ≥3 months as a steroid-sparing option 6, 7
Critical Clinical Pitfalls
Do not prescribe montelukast for atopic dermatitis based on anecdotal reports or older case series 2. The highest-quality placebo-controlled evidence does not support its use, and current guidelines explicitly state there is insufficient evidence 1.
Do not delay appropriate evidence-based systemic therapy (such as dupilumab or cyclosporine) in patients with moderate-to-severe disease by attempting a trial of montelukast 1.
Recognize that montelukast's established efficacy in asthma and allergic rhinitis does not translate to atopic dermatitis, as the pathophysiology differs significantly 2, 5.