Jornal de Cosmetologia e Tricologia

Efficacy and Safety of a Topical Pediatric Gel in Infants with Pityriasis capitis: A Randomized Phase III Controlled Trial

Abstract

Patrice Plantin,Virginie Ribet and Sayda Ben Becher

Objective: Cradle cap is a multifactorial pediatric skin condition characterized by inflammation, irritation, and scalp flaking. The aim of this international, phase III, open-labeled, randomized, parallel-group study was to demonstrate the efficacy and safety of a pediatric gel (spring water, glycerol, panthenol, lactamide, PEG-60 almond glycerides, zinc sulfate), in addition to standardized hygiene, in infants suffering from cradle cap and/or mild to moderate seborrheic dermatitis.

Methods: During the 6 week study period, infants were randomly assigned to receive the study gel (gel group, n=65), applied before a standardized shampoo every day from the inclusion visit on Day 0 to Day 7 and every second or third day from Day 8 to Day 42, or only the daily shampoo (control group, n=62). Due to the absence of a published reference score, a total lesion score (combining measures of both the area involved and scale severity in each scalp quadrant; range 0-64) was used to evaluate efficacy.

Results: Significantly greater improvements in the total lesion scores were observed in infants from the gel group compared with those in the control group at D7 (-12.8 ± 8.1 versus -8.5 ± 6.9, p=0.002), D21 (-18.9 ± 9.8 versus -14.3 ± 9.6, p=0.009) and D42 (-22.3 ± 10.8 versus -17.5 ± 9.8, p=0.01). Complete recovery was reported in 73% of infants in the gel group, compared with only 50% in the control group (p=0.01). "Very good/Good" gel tolerance was observed in more than 98% of infants.

Conclusion: The cradle cap gel efficiently reduced Pityriasis capitis from the first post-inclusion visit on day 7 and tolerance was satisfactory in this specific population. This gel, in addition to a daily hygiene routine, provides a good alternative to commonly used treatments. Combined with use of a mild shampoo, it could be used for first line topical care of infants with cradle cap, with or without mild to moderate seborrheic dermatitis.