A Double-Blind, Placebo-Controlled Pilot Study to Estimate the Efficacy and Tolerability of a Nonsteroidal Cream for the Treatment of Cradle Cap (Seborrheic Dermatitis)

April 2013 | Volume 12 | Issue 4 | Original Article | 448 | Copyright © April 2013


Elmer David MD,a Hanan Tanuos MD,a Timothy Sullivan MD,b Albert Yan MD,c and Leon H. Kircik MDd-f

aUniversity of Medicine and Dentistry, University Hospital Clinical Research Center, Newark, NJ
bNorwich Pediatric Group, Norwich, CT
cChildren’s Hospital of Philadelphia, Pediatric Dermatology, Philadelphia, PA
dMount Sinai Medical Center, New York, NY
eIndiana University School of Medicine, Indianapolis, IN
fPhysicians Skin Care, PLLC, Louisville, KY

Abstract
This study was a multicenter, double-blind, placebo-controlled, parallel-group pilot study of efficacy and tolerability of a nonsteroidal cream (Promiseb® Topical Cream; Promius Pharma, LLC, Bridgewater, NJ) for treatment of cradle cap when applied topically twice daily for up to 14 days in 42 pediatric subjects. Both treatments were similarly effective in reducing disease severity, as measured by success with Investigator's Global Assessment scores at day 7 or end of treatment, with 96% of subjects achieving success in the nonsteroidal cream group and 92% of subjects achieving success in the placebo cream group. Both treatments resulted in significant reductions from baseline in terms of erythema, crusting, scaling, and oiliness (P<.05), with no significant difference between treatments. There was a significant difference (P=.03) between treatment groups for percent reduction in scaling at the end of treatment, with a 90% reduction in the nonsteroidal cream group compared with a 58% reduction in the placebo cream group. All subjects in both groups had an overall safety score of excellent, and there were no adverse events related to treatment for either group.

J Drugs Dermatol. 2013;12(4):448-452.

INTRODUCTION

Cradle cap, sometimes known as pityriasis capitis, is a form of seborrheic dermatitis that manifests as yellowish, crusty, greasy patches of scaling on the scalp of infants between the second week and sixth month of life.1 Overactive sebaceous glands release a greasy substance that inhibits skin cell shedding and creates a buildup. Cradle cap is usually not pruritic and does not bother the infant, although it can be a stressor for parents.1,2
The etiology of seborrheic dermatitis is multifactorial and includes increased sebaceous gland activity, Malassezia species colonization, and individual susceptibility.3 A potential link with increased concentrations of the yeast Malassezia furfur has been noted, but a causative mechanism has not been identified.1 While the etiology of cradle cap is not clearly known, it is not caused by an infection, allergy, or poor hygiene. Possibly the mother’s hormones still in the baby’s circulation lead to overactive sebaceous glands in the skin of newborns. Early sebaceous gland activity in the neonate may result in microfloral colonization and cradle cap.3
Home remedies may be appropriate for treatment of mild cases of cradle cap, although no studies appear to have been performed regarding home treatments. A popular treatment is to apply an emollient such as petroleum jelly or mineral oil liberally and then brush away the softened scales with a soft brush or comb. If not done very gently, however, this can worsen the condition and bring about temporary hair loss. If the cradle cap condition thickens, turns red and irritated, starts to spread, appears on other body parts, or if the baby develops a persistent diaper rash, medical intervention is recommended.
Numerous treatments for seborrheic dermatitis with proven efficacy for adults have been adopted for use in infants, including topical antifungals, antidandruff shampoos with zinc pyrithione or selenium sulfide, coal tar preparations, and episodic use of topical corticosteroids. However, randomized controlled trials of significant size are essentially absent in this age group.1 There is disagreement regarding the role of shampoos in the treatment of cradle cap. Keratolytic shampoos, such as those with sulfur, selenium, zinc pyrithione, or salicylic acid, are generally not recommended because of the possibility of systemic absorption in newborns. In addition, these shampoos may sting the eyes and could worsen the dermatitis. Based on a few small studies, ketoconazole in the form of shampoo or cream appears to be safe and effective for infants.4,5
Obviously, safety is a primary concern when treating infants. While topical corticosteroids have been used in the treatment
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