PMID- 23377341
OWN - NLM
STAT- MEDLINE
DCOM- 20130806
LR  - 20211203
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 12
IP  - 1
DP  - 2013 Jan
TI  - Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic 
      dermatitis: results of a phase IV, open-label study.
PG  - e1-6
AB  - BACKGROUND: Ketoconazole foam, 2%, is approved in the United States for 
      seborrheic dermatitis therapy in immunocompetent patients aged >/=12 years. While 
      short-term trials have demonstrated its safety and efficacy, seborrheic 
      dermatitis often requires long-term treatment. OBJECTIVE: To assess the long-term 
      safety of ketoconazole foam, 2%, twice daily, as required. METHODS: A 12-month, 
      open-label, multicenter study. Subjects were evaluated at baseline and at weeks 
      4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), 
      serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as 
      Investigator's Static Global Assessment (ISGA) scores. Physical examinations were 
      performed at baseline and at week 52/ET, and laboratory evaluations at baseline 
      and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was 
      completed. RESULTS: Of 500 subjects enrolled, 498 were included in the safety 
      population, and 363 completed the study. Overall, 57% of subjects reported >/=1 AE. 
      Treatment-related AEs occurred in 14% of subjects, including application-site 
      irritation (8%), application-site pain (4%), application-site pruritus (1%), and 
      increased alanine aminotransferase (1%). Seven subjects were withdrawn because of 
      treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related 
      to study drug. Mean target lesion erythema, scaling, and pruritus scores improved 
      by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit 
      at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 
      67% of subjects. LIMITATIONS: Evaluation of severity was limited to target 
      lesion; no objective measure of adherence. CONCLUSION: The long-term safety 
      profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was 
      favorable and efficacy was maintained.
FAU - Draelos, Zoe D
AU  - Draelos ZD
AD  - Department of Dermatology, Duke University School of Medicine, Durham, NC, USA. 
      zdraelos@northstrate.net
FAU - Feldman, Steven R
AU  - Feldman SR
FAU - Butners, Victoria
AU  - Butners V
FAU - Alio Saenz, Alessandra B
AU  - Alio Saenz AB
LA  - eng
SI  - ClinicalTrials.gov/NCT00703846
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Antifungal Agents)
RN  - 0 (Pharmaceutical Vehicles)
RN  - R9400W927I (Ketoconazole)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antifungal Agents/*adverse effects/*therapeutic use
MH  - Child
MH  - Chronic Disease
MH  - Dermatitis, Seborrheic/*drug therapy/pathology
MH  - Endpoint Determination
MH  - Ethnicity
MH  - Female
MH  - Humans
MH  - Ketoconazole/*adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance
MH  - Patient Preference
MH  - Pharmaceutical Vehicles
MH  - Sample Size
MH  - Sex Factors
MH  - Young Adult
EDAT- 2013/02/05 06:00
MHDA- 2013/08/07 06:00
CRDT- 2013/02/05 06:00
PHST- 2013/02/05 06:00 [entrez]
PHST- 2013/02/05 06:00 [pubmed]
PHST- 2013/08/07 06:00 [medline]
AID - S1545961613E0001X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2013 Jan;12(1):e1-6.