A controlled, parallel, randomized, stratified (by age using a randomization software) study was carried out on 180 Filipino infants (age 1 day to <1 year). The baseline characteristics of the three groups are given in Table I. The net baseline characteristics were similar for all groups. These infants were in good health and had a normal skin. Prematurely born infants and those with congenital problems were excluded. An ethical clearance was obtained from the Institutional Research Board and written informed consent was taken from the parents.

Table I



Baseline Characteristics of the Study Population (Each group, N=60)

Clinical assessment: A dermatologist evaluated the infant for erythema, edema, dryness and scaling in four areas: head, upper limbs, body, lower limbs. A 5 point rating scale was used, where 0 indicated absence of symptoms and 5 indicated the most severe symptoms. The percentage area affected in each of the four body areas was also evaluated using the following scale: 0 = 0%, 1 =1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 70-100%.

Consumer assessment: Parents were given a diary to note down comments or any observations and reactions with the use of the test product daily. A questionnaire was also administered to the parents/guardians after 1 and 2 weeks to check for consumer perception of the efficacy and side-effect (irritation) of the product.

Statistical analysis: Means were compared by analysis of variance (ANOVA) on related samples test (Friedman Wilcoxon) was done to check for significance between baseline and succeeding time points. P <0.05 was taken as significant.

According to the instrumental assessment for moisture, both Group I and Group II treated subjects had significant increase in moisture level after 1 week of use but by the second week, moisture levels reverted to just above baseline levels (12% and 6% higher, respectively). Group I and III subjects had significant decrease in pH after 1 week of usage but the pH returned to baseline values by the second week. No changes in pH were noted in group II (Table II). SM elicited only a relative increase in trans-epidermal water loss (TEWL) at 2 weeks, however this appeared to be insignificant as the moisture content with SM was more than JTT at baseline and was comparable to baseline. No significant changes in TEWL were noted in group I group III, as compared to baseline values. Other results of instrumental assessment are shown in Table II.

TABLE II



Comparison of Skin Moisture, Surface pH, Transepidermal Water Loss, Oxyhemoglobin and Deoxyhemoglobin, 

After Application of Johnson’s Top-to- Toe cleanser, Sebamed Baby Liquid cleanser and Water

On consumer self-assessment, all the attributes (skin is not dry/skin is not irritated/skin feels soft and smooth/skin is clean/skin is not red/ good for everyday cleaning/protects baby’s sensitive skin) were graded as 4 or 5 which corresponded to either "agree" or "strongly agree", respectively to the stated attribute. No significant differences were noted when comparing all the products versus each other.

In group I, 1/60 subject had mild rashes and redness on the neck and arms that appeared around 4 days after use. The irritation appeared 2-3 hours after bathing and lasted for a few minutes. In group II, 2/60 subjects had irritation in the first week. These were mild rashes or the back and leg and lasted for 1-2 days. For group II, 1/60 subject had mild rashes and dryness 3 days after starting use of the product. No irritation was noted with any of the three compounds in the second week.

The skin of the neonate and infant is thought to be more sensitive than that of adults and differs in some characteristics(1,6,7). The skin’s "barrier function" mainly resides within the stratum corneum layer of the epidermis. It consists of the keratinocytes (constituting of proteins and lipids), embedded in a lipid rich matrix consisting of cholesterol, ceramides and fatty acids. Another class of lipids is also secreted at the surface of the epidermis, which when in contact with the environment interacts with water forming the hydrophilic film, which is important for the sensorial attributes of the skin. The lipid fraction of this hydrophilic film can also penetrate in the upper layers of the epidermis merging with the epidermal barrier and also contributing to its functions(8,9). The use of soaps or detergents (containing surfactants) can have a deleterious effect on the "barrier function" of the skin(10-13). Alkaline soaps and detergents also disturb the physiological "acid mantle", changing the composition of the cutaneous bacterial flora and the activity of enzymes in the upper epidermis, which have an optimum acid pH(3). All this can result in skin dryness, roughness, flakiness and a tightening effect(10,11). Thus, choosing the cleanser for the skin of the newborn and infants to choose from the available classic soaps, liquid soaps, and soapless synthetic detergents or syndets, needs caution(4,5).

In the present study, no statistically significant irritation was visible to the clinician for all three groups of the study, showing that the new liquid cleanser formulation, a well established market product (a cleanser) and warm tap water, were mild on the baby skin. The moisture content in one group others at study initiation, and comparable with baseline. This was the drawback of the study. Further studies of a similar nature, with the cleansers being tested having comparable baseline values are required to draw firm conclusions.

Based on dermatological, instrumental and consumer self-assessment, there were no tolerance issues with any of the three compounds and hence all three can be considered safe for use in infants with normal skin.

Contributors: MDV conceived and designed the study and revised the manuscript. She will act as guarantor of the study; CG, RE, NM, RG collected the data and interpreted the laboratory tests and data and helped in drafting the manuscript; RS helped in manuscript writing and critically revised the manuscript for intellectual content. The final manuscript was approved by all authors.

Funding: Johnson and Johnson.

Competing interests: CG, RE, NM, and RG are the employees of Johnson and Johnson Pvt ltd, which funded this study and who are the manufacturers of JTT, the product evaluated in this study.