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RELIEF-AD: Real-world effectiveness of mometasone furoate in itch reduction in pediatric atopic dermatitis
*Corresponding author: Sheela Pralhad Gaikwad, Department of Global Medical Affairs, Glenmark Pharmaceutical Ltd., Mumbai, Maharashtra, India. sheelapg1807@gmail.com
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Received: ,
Accepted: ,
How to cite this article: De A, Dhoot D, Gaikwad SP. RELIEF-AD: Real-world effectiveness of mometasone furoate in itch reduction in pediatric atopic dermatitis. Indian J Skin Allergy. doi: 10.25259/IJSA_31_2026
Dear Editor,
Atopic dermatitis (AD) is a chronic inflammatory skin disease driven by dryness, barrier dysfunction, and persistent itch, causing sleep disturbance, psychosocial burden, and impaired quality of life for both children and caregivers.[1] Dry skin lowers the itch threshold through increased intraepidermal nerve fibers and sensory nerve sensitization mediated by keratinocyte-derived interleukin (IL)-33. This makes the skin highly responsive to mechanical and chemical itch triggers. Scratching further damages the skin barrier, allowing allergen penetration and promoting type 2 inflammation. T-helper 2(Th2) cytokines, including IL-4, IL-13, and IL-31, amplify sensory nerve sensitization, creating a self-perpetuating itch-scratch cycle that drives disease burden. Therefore, effective itch control is central to AD management.[2]
Topical corticosteroids inhibit T-cell proliferation and reduce pro-inflammatory cytokine production responsible for itch[3] and hence remain the first-line anti-inflammatory therapy.[4] Among available agents, mometasone furoate is a mid-potent topical corticosteroid with strong glucocorticoid-receptor affinity, once-daily dosing, and a favorable therapeutic index when used appropriately.[5] However, real-world evidence focused on patient-perceived itch reduction in Indian children treated with mometasone furoate is limited.
We report findings from a large, multicenter, retrospective, real-world study conducted across India evaluating patient-reported outcomes following short-term use of mometasone furoate 0.1% cream in pediatric patients with mild to moderate AD. Improvement in itch was assessed using patient-reported outcomes on a 10-point scale. Scores of 8–10 were categorized as clear/almost clear response, scores of 1–3 as inadequate response, and intermediate scores (4–7) represented partial to moderate symptom control. Time to symptom improvement and safety outcomes were also analyzed using descriptive statistics. Data were collected retrospectively using a pre-designed structured data collection pro forma and standardized patient reported outcome measures (PROMs) questionnaire. The study protocol and data collection procedures were reviewed and approved by an Independent Ethics Committee (Good Society for Ethical Research; approval dated July 10, 2025).
PROMs were recorded from 1,084 children aged 2–12 years, treated with once-daily mometasone furoate 0.1% cream for 7 days across 408 centers nationwide. The majority of patients had mild disease (61.1%), with the remainder classified as moderate (38.9%). Importantly, none had severe AD, reflecting typical outpatient pediatric dermatology practice. About 23.7% of patients had facial lesions, followed by truncal lesions in 24.45% of patients. Beyond these, lesions were observed on the back (11.3%), limbs (6.9%), and various combinations involving face, trunk, back, and limbs. After 7 days of treatment, the mean patient-reported score for control of itching was 7.7 ± 2.0 on a 10-point scale, indicating good to very good perceived relief. Over 66% of children/caregivers reported high itch-control scores (8–10), while only 6% reported inadequate relief (score of 1–3). Notably, itch reduction was rapid, with a mean time to improvement of 4.5 days, and nearly one-quarter of patients experiencing relief within 3 days. These findings underscore an early onset of antipruritic effect, a clinically meaningful attribute given the central role of pruritus in perpetuating the itch-scratch cycle.[1,4] During the 7-day treatment period, irritation/burning was reported in 39 patients (3.6%), treatment-emergent itching in 36 patients (3.3%), and skin redness in 32 patients (3.0%). More than 95% of participants did not report any of these events. No severe adverse reactions were reported.
The rapid real-world itch improvement observed within a median of 4.5 days is consistent with the pharmacologic profile of mometasone furoate 0.1%, which is characterized by high glucocorticoid receptor affinity and potent anti-inflammatory activity. Strong receptor binding enhances local cutaneous activity and prolongs anti-inflammatory effects, enabling effective suppression of AD-associated inflammation and pruritus with once-daily application. This combination of rapid efficacy and low systemic bioavailability supports the established role of mometasone furoate as an effective short-term treatment for pediatric AD flares.[2-7]
Indian and international guidelines emphasize the importance of using topical corticosteroids for the shortest effective duration in children.[4,8] The present real-world data provide practical reassurance to clinicians that short-term use of mometasone furoate 0.1% cream can deliver rapid itch relief with good tolerability in routine pediatric dermatology practice in India.
This study has several strengths, including a large sample size, broad geographic representation, and emphasis on patientreported outcomes, which are particularly relevant for subjective symptoms such as pruritus. Limitations include its retrospective design, absence of a comparator arm, and reliance on recall-based reporting rather than validated itch scales. Nevertheless, the consistency of benefit across a large, heterogeneous cohort enhances the external validity and clinical relevance of the findings.
In conclusion, this multicenter real-world study demonstrates that shortterm use of mometasone furoate 0.1% cream provides rapid, clinically meaningful itch reduction in children with mild to moderate AD, with good tolerability in routine practice. These findings support its role as an effective short-course option for flare management in pediatric AD, particularly when rapid itch relief is a priority.
Acknowledgment:
We would like to extend our thanks to all the institutes and respective investigators and team members for their support. We also appreciate the Clinical Research Organization (CRO) support by Lifecom Scientia LLP, India, for end-to-end clinical trial management. We also thank Mr. Kiransing Pawar (Glenmark Pharmaceuticals) for her project management support in the study.
Ethical approval:
The research/study was approved by the Institutional Review Board at Good Society Ethical Research, number GSER/2025/BMR/CL/199, dated July 10, 2025.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given consent for clinical information to be reported in the journal. The patient understands that the patient’s names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest:
Dr. Abhishek De is on the Editorial Board of the Journal. Dr. Dhiraj Dhoot and Dr. Sheela Pralhad Gaikwad are employees of Glenmark Pharmaceutical Ltd.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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