PMID- 29030864
OWN - NLM
STAT- MEDLINE
DCOM- 20190422
LR  - 20190422
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 178
IP  - 2
DP  - 2018 Feb
TI  - Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 
      0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis 
      on the face or scalp.
PG  - 433-442
LID - 10.1111/bjd.16048 [doi]
AB  - BACKGROUND: Ingenol mebutate (IngMeb) and diclofenac sodium (DS) are approved 
      treatments for actinic keratosis (AK). OBJECTIVES: To compare the efficacy and 
      safety of IngMeb 0.015% gel with DS 3% gel (NCT02406014). METHODS: Patients with 
      4-8 visible, discrete AK lesions on the face/scalp in a 25 cm(2) contiguous area 
      of skin were randomized 1:1 to IngMeb once-daily for three consecutive days or DS 
      twice-daily for 90 days. Patients with AK lesions at Week 8 following IngMeb were 
      offered a second IngMeb course. Primary end point was complete clearance of AK 
      lesions (AKCLEAR 100) at end of first treatment course (Week 8, IngMeb; Week 17, 
      DS). Secondary end points included AKCLEAR 100 at end of last treatment course 
      and Week 17; adverse events (AEs) were assessed at these time points. Patients 
      completed treatment satisfaction questionnaires for medication (TSQM; Week 17). 
      RESULTS: AKCLEAR 100 at end of first treatment course was higher with IngMeb 
      (34%) vs. DS (23%; P = 0.006). AKCLEAR 100 at end of last IngMeb course (53%) and 
      Week 17 (45%) was higher than DS (both P < 0.001). The most frequent AE was 
      application-site erythema (IngMeb 19%; DS 12%). Treatment-related AE (TRAE) 
      duration was shorter with IngMeb. TRAE withdrawals were lower for IngMeb (2%) vs. 
      DS (6%). TSQM scores for global satisfaction (P < 0.001) and effectiveness 
      (P = 0.002) were higher with IngMeb, as was dosing instruction adherence (>/= 90% 
      vs. 70%). CONCLUSIONS: AKCLEAR 100, patient treatment satisfaction and 
      effectiveness were significantly higher with IngMeb compared with DS, 
      demonstrating superiority of IngMeb for AK treatment on face/scalp.
CI  - (c) 2017 British Association of Dermatologists.
FAU - Stockfleth, E
AU  - Stockfleth E
AUID- ORCID: 0000-0002-1922-9062
AD  - Klinik fur Dermatologie, Venerologie und Allergologie, St. Josef-Hospital, 
      Bochum, Germany.
FAU - Harwood, C A
AU  - Harwood CA
AUID- ORCID: 0000-0002-1375-0965
AD  - Centre for Cell Biology and Cutaneous Research, Blizard Institute, Barts and the 
      London School of Medicine and Dentistry, Queen Mary University of London, London, 
      U.K.
FAU - Serra-Guillen, C
AU  - Serra-Guillen C
AD  - Department of Dermatology, Instituto Valenciano de Oncologia, Valencia, Spain.
FAU - Larsson, T
AU  - Larsson T
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Osterdal, M L
AU  - Osterdal ML
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Skov, T
AU  - Skov T
AD  - LEO Pharma A/S, Ballerup, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT02406014
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180115
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (3-ingenyl angelate)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Diterpenes)
RN  - 0 (Gels)
RN  - 144O8QL0L1 (Diclofenac)
SB  - IM
CIN - Br J Dermatol. 2018 Mar;178(3):812-813. PMID: 29205276
CIN - Br J Dermatol. 2018 Mar;178(3):813-814. PMID: 29206275
CIN - Br J Dermatol. 2018 Feb;178(2):322-323. PMID: 29441544
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Diclofenac/*administration & dosage/adverse effects
MH  - Diterpenes/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Facial Dermatoses/*drug therapy
MH  - Female
MH  - Gels
MH  - Humans
MH  - Keratosis, Actinic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Scalp Dermatoses/*drug therapy
MH  - Treatment Outcome
EDAT- 2017/10/17 06:00
MHDA- 2019/04/23 06:00
CRDT- 2017/10/15 06:00
PHST- 2017/10/04 00:00 [accepted]
PHST- 2017/10/17 06:00 [pubmed]
PHST- 2019/04/23 06:00 [medline]
PHST- 2017/10/15 06:00 [entrez]
AID - 10.1111/bjd.16048 [doi]
PST - ppublish
SO  - Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.