Safety and efficacy of personal care products containing colloidal oatmeal

Figures & data

Table 1 Scoring methods used for evaluation of irritation/allergic skin reaction

Grade	Description
US studies: induction period and challenge period (ICDRG-modified scoring scale for dermatitis^Citation11)
0	No visible reaction
±	Faint, minimal erythema
1	Erythema
2	Intense erythema, induration
3	Intense erythema, induration, vesicles
4	Severe reaction with erythema, induration, vesicles, pustules (including weeping)
E	Indicates presence of edema
Romanian studies: induction period
−	No evidence of any effect
1	Mild (pink, uniform erythema)
2	Moderate (pink-red erythema)
3	Marked (bright red erythema with/without petechiae or papules)
4	Severe (deep red erythema with/without vesiculation or weeping)
Romanian studies: challenge period (ICDRG scoring scale)
−	Negative
+?	Doubtful reaction (slight erythema)
+	Weak reaction (nonvesicular reaction)
++	Strong reaction (erythema, edema, and/or vesicles)
+++	Severe reaction with blisters

Abbreviation: ICDRG, International Contact Dermatitis Research Group System.

Table 2 Summary of repeat insult patch testing studies

Test material	Date/country	Participants	Application	Results
Lotion	June–July 2005, US	245 included/ 207 completed 66 male, 141 female Aged 18–70 years	Occlusive	No reaction during induction phase or challenge phase Conclusion: no potential for dermal irritation or sensitization
Lotion	December 2001– January 2002, US	226 included/ 209 completed 55 male, 154 female Aged 18–69 years	Occlusive	Induction phase: one transient low-level ± reaction in one subject (reading 1) Challenge phase: three low-level ± reactions in one subject (48, 72, 96); one level 1 + edema reaction (72 hours), one transient low-level reaction (1) in one subject (96 hours) Remarks: test material did induce an edematous reaction indicative of dermal sensitization in one human subject This reaction was not confirmed by a second patch testing Conclusion: no potential of the product for dermal sensitization
Lotion SPF15	July–August 2001, US	221 included/ 193 completed 55 male, 138 female Aged 18–69 years	Semiocclusive	No reaction during induction phase or challenge phase Conclusion: no potential for dermal irritation or sensitization
Cleansing lotion	February–April 2005, US	227 included/ 206 completed 66 male, 140 female Aged 18–70 years	Semiocclusive	Induction phase: two transient low-level ± reactions in one subject (readings 1, 2); three transient low-level ± reactions in one subject (readings 7–9) Challenge: no reactions Conclusion: no potential for dermal irritation or sensitization
Cleansing lotion	February–April 2000, US	213 included/ 183 completed 48 male, 135 female Aged 18–69 years	Occlusive	Induction phase: one transient low-level ± reaction in two subjects (readings 6, 8); two transient low-level ± reactions in two subjects (readings 4, 5); four low level transient reactions (1 × 1; 3 × ±) in 1 subject (readings 2–5) Challenge phase: one transient low-level reaction (±) in four subjects (24 hours, 3 × 48 hours); two transient low-level reactions (1; ±) in one subject (48 hours, 72 hours) Conclusion: no potential for dermal irritation or sensitization
Cream	December 2005– January 2006, US	240 included/ 224 completed 59 male, 165 female Aged 18–69 years	Occlusive	No reaction during induction phase Challenge phase: one transient low-level reaction (±) in one subject (48 hours); two transient low-level ± reactions in one subject (48 hours, 72 hours) Conclusion: no potential for dermal irritation or sensitization
Night cream	July–August 2006, US	240 included/ 217 completed 68 male, 149 female Aged 18–70 years	Semiocclusive	Induction phase: one transient low-level ± reaction in two subjects (readings 2) Challenge phase: two transient low-level ± reactions in one subject (48 hours, 72 hours) Conclusion: no potential for dermal irritation or sensitization
Serum	July–August 2006, US	240 included/ 217 completed 68 male, 149 female Aged 18–70 years	Semiocclusive	Induction phase: one transient low-level ± reaction in three subjects (readings 2, 9, 9); one transient low-level reaction (1) in one subject (reading 5); two transient low-level reactions (1; ±) in one subject (readings 5, 6) Challenge phase: one level 1 + edema reaction (48 hours), two low-level transient reactions (1) in one subject (24 hours, 72 hours); two transient low-level reactions (1; ±) in one subject (48 hours, 72 hours) Remark: test material did induce an edematous reaction indicative of dermal sensitization in one human subject; reaction not confirmed by a second patch testing Conclusion: no potential of the product for dermal sensitization
Baby cream	February–March 2009, Romania	114 included/ 109 completed 13 male, 96 female Aged 18–70 years	Semiocclusive	Induction phase: one mild erythema (1) in one subject (reading 3)1 Challenge phase: no reaction Conclusion: no potential for dermal irritation or sensitization
Handcream	May–June 2002, US	240 included/ 201 completed 59 male, 142 female Aged 18–70 years	Semiocclusive	Induction phase: two transient low-level reactions (1; ±) in one subject (readings 3, 4); eight low-level reactions (±) in one subject (readings 2–9) Challenge phase: one transient low-level reaction (±) in one subject (72 hours); three level 1 + edema reactions in one subject (48 hours, 72 hours, 96 hours) Remarks: test material did induce an edematous reaction indicative of dermal sensitization in one human subject; reaction confirmed with the finished product by a second patch testing but not with Avena sativa Conclusion: doubtful
Exfoliating cleanser	March–May 2009, Romania	114 included/ 109 completed 23 male, 86 female Aged 18–68 years	2% dilution, semiocclusive	No reaction during induction phase or challenge phase Conclusion: no potential for dermal irritation or sensitization
Wash (head-to-toe)	August– September 2007, US	245 included/ 216 completed 59 male, 157 female Aged 18–70 years	8% dilution, occlusive	Induction phase: one transient low-level ± reaction in three subjects (readings 2, 7, 7); one transient low-level reaction (1) in one subject (reading 2); two transient low-level reactions (1; ±) in one subject (readings 7, 8) Challenge phase: two transient low-level reactions (1; ±) in two subjects (48 hours, 72 hours); three transient low-level reactions (2 × 1; 1 × ±) in one subject (48 hours, 72 hours, 96 hours) Conclusion: no potential for dermal irritation or sensitization

Note:

1 Note that different scoring methods were used at the two study sites.

Table 3 Summary of safety-in-use studies

Test material	Date/country	Participants	Application	Result (number of subjects with reaction/total number of subjects)
		Skin/hair type1 and skin/eye sensitivity1 (if applicable)
Shower and bath oil	December 2006, UK	60 included (dry, very dry body skin), 53 completed (skin sensitivity: 19% not sensitive, 47% a little sensitive, 23% sensitive, 11% very sensitive) Aged 18–55 years Female	Use product on seven consecutive days instead of usual shower product	Adverse reaction: 3.8% 2/53 (one moderate, one slight)
Cream moisturizing oil	December 2006, UK	60 included (dry, normal to dry body skin), 56 completed (skin sensitivity: 23% not sensitive, 52% a little sensitive, 21% sensitive, 4% very sensitive) Aged 18–55 years Female	Use product once a day on seven consecutive days instead of usual body moisturizer	Adverse reaction: 3.6% Two of 56 (one severe, one moderate)
Shower gel	August 2006, UK	60 included (dry, sensitive body skin), 59 completed (skin sensitivity not indicated) Aged 20–50 years Female	Use product on seven consecutive days instead of usual shower product	Adverse reaction: 3.4% Two of 59 (two moderate)
Night cream	April–May 2009, UK	70 included (facial skin: normal, dry, normal to dry, normal to greasy, normal/dry/greasy) 64 completed (skin sensitivity: 5% not sensitive, 61% a little sensitive, 30% sensitive, 5% very sensitive) Aged 25–49 years Female	Use product on 28 consecutive days instead of usual night-time moisturizer	Adverse reaction: 10.9% Seven of 64 (five subjects with slight to moderate reactions, one subject with moderate to severe reactions, and one subject with severe reactions)
Conditioning shampoo	January–February 2007, UK	60 included (all hair types) Male 30, female 30 55 completed Aged 18–55 years	Use product on 10 occasions, no use of conditioner	Adverse reaction: 3.6% Two of 55 (two moderate)
Body lotion	November–December 2006, UK	60 included (dry, normal to dry body skin), 57 completed (skin sensitivity: 12% not sensitive, 39% a little sensitive, 19% sensitive, 30% very sensitive) Aged 18–55 years Female	Use product on seven consecutive days as frequently as required	Adverse reaction: 0%
Liquid hand wash	October 2006, UK	60 included (dry, normal to dry, very dry hand skin), 58 completed (skin sensitivity: 12% not sensitive, 55% a little sensitive, 22% sensitive, 10% very sensitive) Aged 18–55 years Female	Use product on seven consecutive days as frequently as required instead of usual hand wash product	Adverse reaction: 5.2% Three of 58 (one slight and two moderate)
Facial exfoliating cleanser	March–April 2009, Bulgaria	62 included (normal, mixed oily, oily, mixed dry, dry skin), 60 completed (sensitive skin 100%, history of atopy 32%), two withdrew consent Aged 18–60 years Female	Use product 1 × per day on face and neck during 3 weeks	Safety evaluation: Adverse reactions observed by dermatologist: 0/60 Adverse reaction reported by subjects: 3/60
Intimate wash	January 2007, Germany	60 included (48% healthy skin, 17% dry skin, 2% sensitive skin, 33% atopic dermatitis/eczema-free interval), 60 completed Aged 18–58 years Female	Use product at least 1 × per day during 4 weeks Subsequent occlusive patch test with 1%, 2%, 5% dilutions, inner forearm for 24 hours	After 4 weeks: adverse reaction: 0 Patch test: no reaction at any concentration
Baby milk	January 2007, Germany	20 adults included (25% normal skin, 20% dry skin, 20% sensitive skin, 35% atopic dermatitis/eczema free interval), 20 completed Aged 21–47 years Six male, 14 female 30 children included (27% normal skin, 20% dry skin, 17% sensitive skin, 37% atopic dermatitis/eczema free interval), 30 completed Aged 8 months to 4 years 11 male, 19 female	Use product at least 2 × per day during 4 weeks Subsequent occlusive patch test with adults only (undiluted), inner forearm for 24 hours	After 4 weeks: adverse reaction: 0 Patch test: no reaction

Note:

1 According to information supplied by subject.

Table 4 Summary of ocular tolerability testing under ophthalmological control (safety-in-use studies)

Test material	Date/country	Participants	Application	Result (number of subjects with reaction/per total number of subjects)
		Skin/hair type^Citation1 and skin/eye sensitivity^Citation1 (if applicable)
Face and eye cleansing lotion	September 2009, Poland	22 included (normally sensitive eyes), 22 completed Aged 18–70 years Female	Use product 2 × per day on face including eye area and neck during 3 weeks	Clinical signs: 0%
Face and eye cleansing lotion	September 2009, Poland	22 included (normally sensitive eyes), 21 completed Aged 18–60 years Female	Use product 2 × per day on face including eye area and neck for 3 weeks	Clinical signs: 14% 3/21 (possibly attributable to product and for two subjects only on one eye)

Figure 1 Skin hydration increases during and after use of oatmeal-containing cream.

Notes: Hydration of the forearm increased significantly during the application period (days 1–28) and afterwards (day 42) compared with baseline. Hydration of the leg increased significantly more compared with the control area at all time points.

Figure 2 Surface area of dead cells and desquamation index diminish with use of oatmeal-containing cream. Surface of dead cells (A) and desquamation rate (B) were compared with baseline for the forearm area and their reduction is indicated as percentage improvement. Data derived from leg measurements was compared with the control area for surface of dead cells (C) and desquamation rate (D).

Abbreviation: NS, not statistically significant.

Figure 3 Clinically assessed parameters improve with use of oatmeal-containing cream.

Note: At all time points, the three parameters assessed, ie, skin dryness, appearance of squamae, and skin roughness, were significantly more improved on the treated leg area compared with the control area.

Figure 4 Subjective evaluation of effect on signs of skin dryness.

Note: The percentage of patients who reported a positive effect on skin dryness is depicted (combination of answers “agree” and “rather agree”).

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