Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry

Elaine C. Siegfried, Jennifer C. Jaworski, Lawrence F. Eichenfield, Amy Paller, Adelaide A. Hebert, Eric L. Simpson, Emily Altman, Charles Arena, Andrew Blauvelt, Julie Block, Mark Boguniewicz, Suephy Chen, Kelly Cordoro, Diane Hanna, Kimberly Horii, Thomas Hultsch, James Lee, Donald Y. Leung, Peter Lio, Joshua MilnerTheodore Omachi, Christine Schneider, Lynda Schneider, Robert Sidbury, Timothy Smith, Jeffrey Sugarman, Sharif Taha, Susan Tofte, Megha Tollefson, Wynnis L. Tom, Dennis P. West, Lucinda Whitney, Lee Zane

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).

Original languageEnglish (US)
Pages (from-to)303-322
Number of pages20
JournalPediatric Dermatology
Volume35
Issue number3
DOIs
StatePublished - May 1 2018

Fingerprint

Atopic Dermatitis
Industry
United States Food and Drug Administration
Clinical Trials
Pharmaceutical Preparations
Skin Diseases
Therapeutics
Drug Approval
Drug Industry
Adrenal Cortex Hormones
Chronic Disease
Guidelines
Population

Keywords

  • atopic dermatitis
  • clinical trials
  • drug development
  • eczema
  • FDA
  • IGA
  • therapy-systemic
  • therapy-topical

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Dermatology

Cite this

Siegfried, E. C., Jaworski, J. C., Eichenfield, L. F., Paller, A., Hebert, A. A., Simpson, E. L., ... Zane, L. (2018). Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry. Pediatric Dermatology, 35(3), 303-322. https://doi.org/10.1111/pde.13452

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age) : Draft guidance for industry. / Siegfried, Elaine C.; Jaworski, Jennifer C.; Eichenfield, Lawrence F.; Paller, Amy; Hebert, Adelaide A.; Simpson, Eric L.; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y.; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L.; West, Dennis P.; Whitney, Lucinda; Zane, Lee.

In: Pediatric Dermatology, Vol. 35, No. 3, 01.05.2018, p. 303-322.

Research output: Contribution to journalArticle

Siegfried, EC, Jaworski, JC, Eichenfield, LF, Paller, A, Hebert, AA, Simpson, EL, Altman, E, Arena, C, Blauvelt, A, Block, J, Boguniewicz, M, Chen, S, Cordoro, K, Hanna, D, Horii, K, Hultsch, T, Lee, J, Leung, DY, Lio, P, Milner, J, Omachi, T, Schneider, C, Schneider, L, Sidbury, R, Smith, T, Sugarman, J, Taha, S, Tofte, S, Tollefson, M, Tom, WL, West, DP, Whitney, L & Zane, L 2018, 'Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry', Pediatric Dermatology, vol. 35, no. 3, pp. 303-322. https://doi.org/10.1111/pde.13452
Siegfried, Elaine C. ; Jaworski, Jennifer C. ; Eichenfield, Lawrence F. ; Paller, Amy ; Hebert, Adelaide A. ; Simpson, Eric L. ; Altman, Emily ; Arena, Charles ; Blauvelt, Andrew ; Block, Julie ; Boguniewicz, Mark ; Chen, Suephy ; Cordoro, Kelly ; Hanna, Diane ; Horii, Kimberly ; Hultsch, Thomas ; Lee, James ; Leung, Donald Y. ; Lio, Peter ; Milner, Joshua ; Omachi, Theodore ; Schneider, Christine ; Schneider, Lynda ; Sidbury, Robert ; Smith, Timothy ; Sugarman, Jeffrey ; Taha, Sharif ; Tofte, Susan ; Tollefson, Megha ; Tom, Wynnis L. ; West, Dennis P. ; Whitney, Lucinda ; Zane, Lee. / Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age) : Draft guidance for industry. In: Pediatric Dermatology. 2018 ; Vol. 35, No. 3. pp. 303-322.
@article{48ba2faf2b74480cb6ca5f3af821add8,
title = "Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry",
abstract = "Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).",
keywords = "atopic dermatitis, clinical trials, drug development, eczema, FDA, IGA, therapy-systemic, therapy-topical",
author = "Siegfried, {Elaine C.} and Jaworski, {Jennifer C.} and Eichenfield, {Lawrence F.} and Amy Paller and Hebert, {Adelaide A.} and Simpson, {Eric L.} and Emily Altman and Charles Arena and Andrew Blauvelt and Julie Block and Mark Boguniewicz and Suephy Chen and Kelly Cordoro and Diane Hanna and Kimberly Horii and Thomas Hultsch and James Lee and Leung, {Donald Y.} and Peter Lio and Joshua Milner and Theodore Omachi and Christine Schneider and Lynda Schneider and Robert Sidbury and Timothy Smith and Jeffrey Sugarman and Sharif Taha and Susan Tofte and Megha Tollefson and Tom, {Wynnis L.} and West, {Dennis P.} and Lucinda Whitney and Lee Zane",
year = "2018",
month = "5",
day = "1",
doi = "10.1111/pde.13452",
language = "English (US)",
volume = "35",
pages = "303--322",
journal = "Pediatric Dermatology",
issn = "0736-8046",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age)

T2 - Draft guidance for industry

AU - Siegfried, Elaine C.

AU - Jaworski, Jennifer C.

AU - Eichenfield, Lawrence F.

AU - Paller, Amy

AU - Hebert, Adelaide A.

AU - Simpson, Eric L.

AU - Altman, Emily

AU - Arena, Charles

AU - Blauvelt, Andrew

AU - Block, Julie

AU - Boguniewicz, Mark

AU - Chen, Suephy

AU - Cordoro, Kelly

AU - Hanna, Diane

AU - Horii, Kimberly

AU - Hultsch, Thomas

AU - Lee, James

AU - Leung, Donald Y.

AU - Lio, Peter

AU - Milner, Joshua

AU - Omachi, Theodore

AU - Schneider, Christine

AU - Schneider, Lynda

AU - Sidbury, Robert

AU - Smith, Timothy

AU - Sugarman, Jeffrey

AU - Taha, Sharif

AU - Tofte, Susan

AU - Tollefson, Megha

AU - Tom, Wynnis L.

AU - West, Dennis P.

AU - Whitney, Lucinda

AU - Zane, Lee

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).

AB - Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).

KW - atopic dermatitis

KW - clinical trials

KW - drug development

KW - eczema

KW - FDA

KW - IGA

KW - therapy-systemic

KW - therapy-topical

UR - http://www.scopus.com/inward/record.url?scp=85046782311&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85046782311&partnerID=8YFLogxK

U2 - 10.1111/pde.13452

DO - 10.1111/pde.13452

M3 - Article

C2 - 29600515

AN - SCOPUS:85046782311

VL - 35

SP - 303

EP - 322

JO - Pediatric Dermatology

JF - Pediatric Dermatology

SN - 0736-8046

IS - 3

ER -