Study of the Efficacy and Tolerability of 0.04% Tretinoin Microsphere Gel for Preadolescent Acne

Eichenfield, Lawrence F.; Matiz, Catalina; Funk, Ann; Dill, Sara W

doi:10.1542/peds.2009-3447

Cited by 20 publications

(25 citation statements)

References 16 publications

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“…With limited FDA‐approved treatment options for preadolescent acne, off‐label prescribing is common. Monotherapy with adapalene gel, tretinoin gel, and tretinoin microsphere gel has been investigated in small open‐label and blinded studies in children under 12 years of age . However, data in preadolescent acne are lacking.…”

Section: Discussionmentioning

confidence: 99%

Novel tretinoin 0.05% lotion for the once‐daily treatment of moderate‐to‐severe acne vulgaris in a preadolescent population

Eichenfield

Sugarman

Guenin

et al. 2019

Pediatric Dermatology

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Background Acne vulgaris (acne) is a common skin condition in children and adolescents. Efficacy of tretinoin is well documented in studies that included pediatric patients (12‐18 years of age). With acne routinely presenting in younger patients, data are needed in this important group. Lotion formulations are commonly used across dermatology and are well liked by patients. Objective To evaluate the safety and efficacy of a novel once‐daily tretinoin 0.05% lotion in preadolescent subjects (≤ 13 years) with moderate‐to‐severe acne. Methods Post hoc analysis of two multicenter, randomized, double‐blind, vehicle‐controlled phase 3 studies in moderate‐to‐severe acne. Preadolescent subjects (N = 154) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2‐grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability evaluated throughout. Results At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% compared with 31.4% and 18.8% with vehicle (both P = 0.001). Treatment success was achieved by 23.7% of subjects by Week 12, compared with 7.2% ( P = 0.009). The majority of AEs were mild and transient: most frequently were application site pain (5.6%) and application site dryness (2.8%). Local cutaneous safety and tolerability assessments were generally mild‐to‐moderate and improved by Week 12. Conclusions Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It was well tolerated, with all treatment‐related AEs deemed mild or moderate.

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Section: Discussionmentioning

confidence: 99%

Novel tretinoin 0.05% lotion for the once‐daily treatment of moderate‐to‐severe acne vulgaris in a preadolescent population

Eichenfield

Sugarman

Guenin

et al. 2019

Pediatric Dermatology

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“…Adapalene gel, tretinoin gel, and tretinoin microsphere gel have been investigated in both open-label and blinded studies in children under 12 years of age. [47][48][49] Retinoids normalize desquamation of the follicular epithelium, thus preventing the formation of new microcomedones, precursors to both comedonal and inflammatory lesions, and also promote the clearing of existing microcomedones. 50 In addition, some topical retinoids also have direct antiinflammatory activity.…”

Section: Prescription Treatment Options: Single Agents Topical Retinoidsmentioning

confidence: 99%

“…In patients with sensitive skin, therapy can be initiated with thriceweekly application, increasing to daily use as tolerated. 48 Tolerability may be further improved by the use of a noncomedogenic moisturizer that includes a sunscreen. 15,38 48 Other topical retinoid alternatives to tretinoin include adapalene and tazarotene.…”

Section: Prescription Treatment Options: Single Agents Topical Retinoidsmentioning

confidence: 99%

“…48 Tolerability may be further improved by the use of a noncomedogenic moisturizer that includes a sunscreen. 15,38 48 Other topical retinoid alternatives to tretinoin include adapalene and tazarotene. Adapalene, a distinct retinoid that is generally well tolerated, is available in cream, gel, and lotion formulations.…”

Section: Prescription Treatment Options: Single Agents Topical Retinoidsmentioning

confidence: 99%

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Evidence-Based Recommendations for the Diagnosis and Treatment of Pediatric Acne

et al. 2013

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INTRODUCTION: Acne vulgaris is one of the most common skin conditions in children and adolescents. The presentation, differential diagnosis, and association of acne with systemic pathology differs by age of presentation. Current acknowledged guidelines for the diagnosis and management of pediatric acne are lacking, and there are variations in management across the spectrum of primary and specialty care. The American Acne and Rosacea Society convened a panel of pediatric dermatologists, pediatricians, and dermatologists with expertise in acne to develop recommendations for the management of pediatric acne and evidence-based treatment algorithms. METHODS: Ten major topic areas in the diagnosis and treatment of pediatric acne were identified. A thorough literature search was performed and articles identified, reviewed, and assessed for evidence grading. Each topic area was assigned to 2 expert reviewers who developed and presented summaries and recommendations for critique and editing. Furthermore, the Strength of Recommendation Taxonomy, including ratings for the strength of recommendation for a body of evidence, was used throughout for the consensus recommendations for the evaluation and management of pediatric acne. Practical evidence-based treatment algorithms also were developed. RESULTS: Recommendations were put forth regarding the classification, diagnosis, evaluation, and management of pediatric acne, based on age and pubertal status. Treatment considerations include the use of over-the-counter products, topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, and isotretinoin. Simplified treatment algorithms and recommendations are presented in detail for adolescent, preadolescent, infantile, and neonatal acne. Other considerations, including psychosocial effects of acne, adherence to treatment regimens, and the role of diet and acne, also are discussed. CONCLUSIONS: These expert recommendations by the American Acne and Rosacea Society as reviewed and endorsed by the American Academy of Pediatrics constitute the first detailed, evidence-based clinical guidelines for the management of pediatric acne including issues of special concern when treating pediatric patients.

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“…The severity of acne was assessed using a six-point rating scale: the Evaluator Global Severity Score [9]. Enrolled participants had a Global Severity Score of 2 or 3 before treatment.…”

Section: Methodsmentioning

confidence: 99%

Photodynamic therapy using 5-aminolevulinic acid and intense pulsed light against intense pulsed light alone in the treatment of acne vulgaris

Ragab¹,

Hussein²,

Salem³

2014

Journal of the Egyptian Womenʼs Dermatologic Society

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BackgroundPhotodynamic therapy (PDT) is one of the promising new modalities for the treatment of acne vulgaris. Objective The aim of this study was to compare the efficacy and safety of PDT using 5-aminolevulinic acid (ALA) with intense pulsed light (IPL) and IPL alone in the treatment of mild to moderate acne vulgaris. Patients and methodsThis was a randomized controlled clinical trial. Twenty-five patients of both sexes with mild to moderate facial acne participated in this study. The patients were divided into two groups: group I included 15 patients who received ALA-PDT using IPL and group II included 10 patients who were treated with IPL only. Both groups received two sessions at 2-week interval. The patients were evaluated clinically at baseline and on the second and the eighth weeks after the last treatment. ResultsThe ALA-PDT group showed significant improvement in treating both inflammatory and comedonal lesions compared with at baseline. In addition, the reduction was greater for inflammatory lesions than for comedonal lesions (73.4 vs. 33.6%). The IPL-only group showed an 18.9% reduction in inflammatory lesions and a 29.8% reduction in comedones. The mean percent reduction from baseline to the end point of treatment in inflammatory lesions was significantly greater in the PDT-IPL group than in the IPL-only group (P = 0.012). Side effects were minimal. Conclusion Analysis of the results revealed that both ALA-PDT with IPL as a light source and IPL alone are efficient and safe treatment modalities for acne vulgaris with superiority of ALA-PDT in reduction of inflammatory lesions.

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Study of the Efficacy and Tolerability of 0.04% Tretinoin Microsphere Gel for Preadolescent Acne

Abstract: The 0.04% TMG pump was effective and safe for the treatment of acne vulgaris in this 8- to 12-year-old population, and the treatment was generally well tolerated. Additional studies in this population are recommended, to confirm these results.

Cited by 20 publications

References 16 publications

Novel tretinoin 0.05% lotion for the once‐daily treatment of moderate‐to‐severe acne vulgaris in a preadolescent population

Novel tretinoin 0.05% lotion for the once‐daily treatment of moderate‐to‐severe acne vulgaris in a preadolescent population

Evidence-Based Recommendations for the Diagnosis and Treatment of Pediatric Acne

Photodynamic therapy using 5-aminolevulinic acid and intense pulsed light against intense pulsed light alone in the treatment of acne vulgaris

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