A phase II, open-label study of the efficacy and safety of imiquimod in the treatment of superficial and mixed infantile hemangioma.
OBJECTIVE
To explore the efficacy and safety of imiquimod 5% cream as a treatment for infantile hemangioma.


METHODS
Phase II, open-label, noncomparative study of imiquimod applied during 16 weeks, with posttherapy follow-up 16 weeks later (8 months total).


METHODS
Outpatient pediatric tertiary care referral center in Quebec, Canada.


METHODS
Healthy infants up to 8.8 months of age with previously untreated, nonulcerated, proliferative superficial or mixed infantile hemangioma, excluding periorbital, or perineal localization, > or =100 cm2 in size.


METHODS
Topical imiquimod applied three to seven times per week for 16 weeks to infantile hemangioma.


METHODS
Lesion area, volume, depth (Doppler ultrasound), and color (erythema), serum drug, and interferon-alpha levels.


RESULTS
Sixteen infants (11 girls, 5 boys) with a mean age at entry of 4.1 months and mean lesion area of 32.89 cm2, and volume of 39.98 cm3 were enrolled. Two participants discontinued treatment early, one for an adverse event (crying upon application), the other because of the lack of compliance. Local skin reactions were consistent with those reported in adults. Two cases had a decrease and three had an increase in lesion parameters; otherwise no meaningful changes in lesion area, volume, or depth were observed. At the 4-month posttreatment visit, 11 of 14 subjects had improvement in erythema (marginal homogeneity test = 2.668, p = 0.008). Measured serum drug and interferon-alpha levels were low or undetectable.


CONCLUSIONS
Treatment of infants with infantile hemangioma with imiquimod up to seven times per week for 16 weeks was generally well tolerated with low systemic exposure. Improvement was observed in hemangioma coloration, but not lesion size, suggesting effects were limited to the superficial component.
McCuaig
Catherine C
CC
Division of Dermatology, Department of Pediatrics, CHU Sainte-Justine, University of Montreal, Montreal, Quebec, Canada. catherine_mccuaig@ssss.gouv.qc.ca
Dubois
Josée
J
Powell
Julie
J
Belleville
Claude
C
David
Michèle
M
Rousseau
Elisabeth
E
Gendron
Roxanne
R
Jafarian
Fatemeh
F
Auger
Isabelle
I
D000287:Administration, Topical; D000634:Aminoquinolines / Q000097:blood / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000097:blood; D006391:Hemangioma / Q000188:drug therapy*; D006801:Humans; D000077271:Imiquimod; D007223:Infant; D016898:Interferon-alpha / Q000097:blood; D008297:Male; D012878:Skin Neoplasms / Q000188:drug therapy*; D042461:Vascular Endothelial Growth Factor A / Q000097:blood / Q000652:urine
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D016898:Interferon-alpha; D042461:Vascular Endothelial Growth Factor A; D016222:Fibroblast Growth Factor 2; D000077271:Imiquimod