Efficacy and Safety of a Topical Pediatric Gel in Infants with Pityriasis capitis: A Randomized Phase III Controlled Trial
Received Date: Oct 27, 2016 / Accepted Date: Jan 02, 2017 / Published Date: Jan 08, 2017
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.
Keywords: Cradle cap; Infants; Mild to moderate seborrheic dermatitis; Pediatric gel; Topical treatment; Randomized controlled trial; Scalp dermatoses
Citation: Plantin P, Ribet V, Becher SB (2016) Efficacy and Safety of a Topical Pediatric Gel in Infants with Pityriasis capitis: A Randomized Phase III Controlled Trial. J Cosmo Trichol 3: 115. Doi: 10.4172/2471-9323.1000115
Copyright: ©2017 Plantin P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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