Commercially available product provided by PZ Cussons Indonesia was investigated in these studies. Cussons Baby Sensicare Gentle Hair and Body Wash is a surfactant base with Dermasoft^TM Complex and Argania spinosa (Argan) kernal oil. The Cussons Baby Sensicare 24 hr Daily Moisturizing Lotion and Cussons Baby Sensicare Intensive Soothing Cream are oil in water emulsion with Dermasoft^TM Complex and Butyrospermum parkii (Shea) Butter. Detail of ingredients list of Cussons Baby Sensicare Range provided in Table 1.

This was a single-centre, within-subject comparison, assessor blinded, randomised study conducted by Alba Science Ltd in 26 healthy volunteers, male and female aged 18 to 70 who had self-assessed sensitive, atopic skin (assessed by completion of a questionnaire).

The Cussons Baby Sensicare Gentle Hair & Body Wash was assessed over 48-hour exposure with 2 consecutive 23-hour patch applications of 2.0% concentration. Cussons Baby Sensicare 24 hours Daily Moisturizing Lotion and the Cussons Baby Sensicare Intensive Soothing Cream were assessed over 96-hour exposure with 4 consecutive 23-hour patch applications. SLS (0.3% w/v) and sterile water were included as controls.

The application area for the test and control products was the upper, outer arms. A randomised product application schedule was generated for each subject to randomly allocate each product to an application site. The order of products in the patch schedule was randomised to eliminate position and order bias.

Approximately 20 µl of each product and control was applied to the skin under an occlusive patch (Finn Chamber 8 mm). Skin markers marked either end of the Finn Chamber to allow exact relocation to the test areas at subsequent applications. Approximately 23 hours after application the subjects removed their patch and washed the test sites to remove residual test and control material. The test sites were assessed approximately 1 hour later by a trained assessor, following the scoring system detailed in Table 2. After assessment, an identical patch was reapplied to the same area for a further period of approximately 23 hours. The test and control materials were reapplied to the same sites as before, following assessment. Any test or control material which elicited erythema or dryness with a score of 5 or more was not reapplied. Any test or control material which elicited a palpable response was not reapplied.

For the 48 h test materials, treatment was over 3 consecutive days, commencing on Day 1 when the test materials were applied as described. The test materials were applied on Days 1 and 2. Skin assessments were on Days 2 and 3. The paediatric consultant was present for skin assessments on Day 3.

For the 96 h test materials, treatment was over 5 consecutive days, commencing on Day 1 when the test materials were applied as described. The test materials were applied on Days 1, 2, 3 and 4. Skin assessments were on Days 2, 3, 4 and 5. The paediatric consultant was present for skin assessments on Day 5.

Erythema, Dryness and Irritation scores are ordinal categorical measurements taken repeatedly on volunteers, so multinomial models coupled with Generalised Estimating Equations (GEEs) were fitted. This method accommodates both the ordinal categorical nature of the response scores and potential correlated errors within subjects. Only the responses at 48h and 96h were considered.

Multiple-comparison adjustments were made to significance levels, where appropriate, to maintain a nominal family-level type I error rate of 5%. All analysis was conducted in SASV 9.4 and RV 3.2.

One hundred (100) healthy female Indonesian and Asian subjects, aged 18 - 55 years old with sensitive skin and uniform pigmentation on the test area were required for study entry. Selection of subjects with sensitive skin was based on a positive skin reaction to a 1% closed patch test with sodium lauryl sulphate (SLS) for 24 hours.

The studies were controlled, within subject, human repeat-insult patch tests (HRIPT) conducted by Assertra Inno Medikos Dermatology Laboratory in Indonesia. Each product (about 20 µl) was applied under an occlusive patch (Finn Chamber 8 mm (50 mm²)) to intact skin on the back of each volunteer every other day for 3 weeks (Induction Phase). The subjects then had a 2 week Rest Phase before the Challenge Phase when subjects were patched again for 24 hours to a previously untreated skin site. An overview of the product application in the RIPTs is provided in Table 3.

Thirty minutes after removal of each patch and prior to the next patch application during the Induction Phase, erythema, oedema, dryness and presence of vesicles were assessed and recorded by a Dermatologist according to the criteria detailed in Table 4. The Mean Cumulative Irritation Index (MCII) across the study population was calculated from these scores using the following formula:

MCII = [ ( ∑ Scores ( D 1 ⋯ D 21 ) Numberofreading ) Sub 1 + ⋯ + ( ∑ Scores ( D 1 ⋯ D 21 ) ( n − 1 ) x 2 Numberofreading ) Sub N NumberofSubjects ( N ) ]

The irritating potential of each product during the Induction Phase was then classified according to MCII as detailed in Table 5.

During the Challenge Phase, skin reactions were scored according to the International Contact Dermatitis Research Group (ICDRG) at 30 minutes, 24 hours, 48 hours and 72 hours after patch removal (Table 6). The sensitization potential of each product was determined from these scores.

ICDRG = International Contact Dermatitis Research Group.

Twenty-nine subjects with self-assessed sensitive, atopic skin were recruited for the study and 27 subjects were screened. Of these, 26 subjects participated in and completed the study (10 males and 16 females). The mean age of study participants was 39.4 years (range 19 - 63 years). The total means of irritation scores (erythema and dryness) are presented in Table 7. All products were significantly lower than the positive control (p < 0.05). The products were not significantly different from the negative control in terms of irritation scores at the respective time points. There were no adverse events reported during the study. All test products were well tolerated during the study.

SLS = sodium lauryl sulphate.

One hundred and forty-five (145) subjects were evaluated with the 1% closed patch test with SLS. From these subjects one hundred and eleven (111) subjects were selected to enter the study, having confirmed sensitive skin. There were seven (7) dropouts and one hundred and four (104) subjects completed the study. The average age of study participants was 34.8 years (range 18 - 53 years).

The Cussons Baby Sensicare Gentle Hair and Body Wash was found to be slightly irritating during the Induction Phase of the RIPT (MCII = 0.183) and non-sensitizing (reaction was only very slight erythema in 23/104 subjects with no persist oedema or infiltration reactions noted). The Cussons Baby Sensicare 24 hours Daily Moisturizing Lotion was found to be very slightly irritating during the Induction Phase of the RIPT (MCII = 0.097) and non-sensitizing (reaction was only very slight erythema in 18/104 subjects with no persist oedema or infiltration reactions noted). The Cussons Baby Sensicare Intensive Soothing Cream was found to be very slightly irritating during the Induction Phase of the RIPT (MCII = 0.078) and non-sensitizing (reaction was only very slight erythema in 12/104 subjects with no persist oedema or infiltration reactions noted). Results are summarised in Table 8.

ICDRG = International Contact Dermatitis Research Group; MCII = Mean Cumulative Irritation Index; HRIPT = Human Repeat Insult Patch Test.