Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010;12(6):PCC.10m00996.
doi: 10.4088/PCC.10m00996pur.

Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD

Erin M Warshaw  1 , Liza Squires, Yunfeng Li, Richard Civil, Amy S Paller
Affiliations

Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD

Erin M Warshaw et al. Prim Care Companion J Clin Psychiatry. 2010.

Abstract

Objective: To characterize dermal reactions and examine methylphenidate (MPH) sensitization in subjects receiving methylphenidate transdermal system (MTS).

Method: This multicenter, open-label, dose-optimization study utilized MTS doses of 10, 15, 20, and 30 mg in children aged 6 to 12 years, inclusive (N = 305), with a DSM-IV-TR primary diagnosis of attention-deficit/hyperactivity disorder. The study was conducted between January 8, 2007, and August 23, 2007. Subjects wore MTS on their hips for 9 hours per day, alternating sides daily for a total of 7 weeks. Assessments included the Experience of Discomfort scale, Transdermal System Adherence scale, and Dermal Response Scale (DRS; 0 = no irritation, 7 = strong reaction). On-study reevaluations were conducted to characterize DRS scores ≥ 4. Epicutaneous allergy patch testing was conducted for DRS scores ≥ 6, persistent DRS scores ≥ 4, DRS score increase following an assessment of ≥ 4, or DRS scores of 4 or 5 following elective discontinuation.

Results: Approximately half of subjects experienced definite erythema at the patch site that generally dissipated within 24 hours. Four subjects experienced a DRS score of 4 (1%): erythema in 1 subject resolved on study treatment, 2 cases resolved poststudy and subjects tolerated oral MPH, and 1 subject discontinued treatment. The latter subject was referred for patch testing and was diagnosed with allergic contact sensitization to MPH.

Conclusions: Few severe dermal effects were seen with MTS treatment. Dermal reactions were characterized as contact dermatitis and dissipated rapidly. On patch testing, 1 subject (0.3%) manifested sensitization to MPH.

Trial registration: clinicaltrials.gov Identifier: NCT00434213.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study Design
Figure 2
Figure 2
Subject Disposition of All Enrolled Subjects aFour subjects were given open-label methylphenidate transdermal system but did not return to the clinic after their baseline visit; these subjects were lost to follow-up. bIncludes 1 subject who discontinued due to an application site reaction.
See this image and copyright information in PMC

References

    1. Bloom B, Dey AN, Freeman G. Summary health statistics for US children: National Health Interview Survey, 2005. Vital Health Stat 10. 2006;231(231):1–84. - PubMed
    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition. Washington, DC: American Psychiatric Association; 2000. Text Revision.
    1. Biederman J, Faraone S, Milberger S, et al. Predictors of persistence and remission of ADHD into adolescence: results from a four-year prospective follow-up study. J Am Acad Child Adolesc Psychiatry. 1996;35(3):343–351. - PubMed
    1. Pliszka S. AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894–921. - PubMed
    1. Bush G, Spencer TJ, Holmes J, et al. Functional magnetic resonance imaging of methylphenidate and placebo in attention-deficit/hyperactivity disorder during the multi-source interference task. Arch Gen Psychiatry. 2008;65(1):102–114. - PubMed

Associated data