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 We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to 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 This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).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 language | English (US) |
|---|---|
| Pages (from-to) | 303-322 |
| Number of pages | 20 |
| Journal | Pediatric Dermatology |
| Volume | 35 |
| Issue number | 3 |
| DOIs | |
| State | Published - May 1 2018 |
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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
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18 years of age) : Draft guidance for industry.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; 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 journal › Article
}
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
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 -