Table 4.
Characteristics of included studies (listed in chronological order)
| Study | NHMRC Level | Population | Sample Size (n male) | Intervention/active ingredients tested | Study duration | Outcome measurements | Inclusion Criteria | Study results | Mean values/Effect size |
|---|---|---|---|---|---|---|---|---|---|
| Nash [30] | IV | M/F, 12 – 87 years | 75 (NR) | 20% urea cream | 7 months | Clinical scoring | UTD | Significant improvement after treatment | N/A |
| Hopp and Sundberg [27] | III-1 | M/F, 60 + yrs | 60 (NR) | Alpha-Keri (oil) vs Keri-lotion ® (both containing lanolin, mineral oil and emulsifiers) vs water soak vs control | 12 days | Questionnaire, Dryness Scale, Panel evaluation |
UTD | Water soak + Keri-lotion was superior to other combinations | Mean difference 1.16 (P < 0.05) |
| Brenner [25] | IV | M/F, 53 – 97 years | 10 (7) | 12% ammonium lactate | 14 days | 7-point Dry Skin Grading Scale | UTD | Significant improvement after treatment | N/A |
| Siskin et al. [29] | III-2 | Sex NR, 24 – 85 years | 55 (NR) | 12% ammonium lactate vs no therapy | 8 weeks | Overall Dryness Severity Score, Physician Global Improvement of Improvement/Worsening |
≥ Moderate bilateral dryness | 12% ammonium lactate superior to no treatment | Mean difference 0.98 (P < 0.05) |
| Jennings et al. [33] | III-3 | M/F, 22 – 86 years | 70 (34) | 5% salicylic acid + 10% urea vs 12% ammonium lactate | 28 days | Xerosis severity scale, Tenderness Scale, VAS |
Mild-moderate bilateral xerosis | No significant difference between treatments | Mean difference 0.1 (P = 0.15) |
| Uy et al. [28] | III - 2 | Sex NR, 13 – 72 years | 57 (NR) | 12% ammonium lactate vs liposome – based emollients (petrolatum, paraffin) | 28 days | Clinical grading scores | ≥ Moderate bilateral dryness and/or hyperkeratosis | No significant difference between treatments | N/A |
| Ademola et al. [2] | III-2 | M/F, 18 – 65 years | 25 (NR) | 40% urea cream vs 12% ammonium lactate | 28 days | Evapirometer (roughness), Corneometer (dryness), D-Squame (scales), VAS |
≥ Grade 2 xerosis Free of cutaneous disease |
40% urea cream superior | Effect size 0.19 (95% CI: −0.47 to 0.84) |
| Jennings et al. [36] | III-3 | M/F, 26 – 83 years | 35 (10) | 10% lactic acid vs 12% ammonium lactate | 28 days | Xerosis severity scale, Tenderness Scale, VAS |
Mild-moderate bilateral xerosis | No significant difference between treatments, patients preference for 10% lactic acid | Mean difference 0.1 (P = 0.9) |
| Pham et al. [7] | III-2 | M/F, age NR | 40 (22) | 10% urea + 4% lactic acid vs placebo vehicle | 28 days | Xerosis Assessment Scale | ≥18 years Type 1 or 2 diabetes Mild-moderate bilateral xerosis |
10% urea + 4% lactic acid superior to placebo vehicle | N/A |
| Baird [20] | III-3 | M/F, age NR | 30 (14) | 10% urea cream vs 25% urea cream | 6 weeks | Customised equipment measuring skin electrical resistance | Type 1 or 2 diabetes Bilateral dry skin |
25% urea cream superior to 10% urea cream | Effect size 0.27 (95% CI: −0.24 to 0.78) |
| Jennings et al. [37] | III-3 | M/F, 18 + yrs | 41 (NR) | Lanolin cream vs 12% ammonium lactate | 28 days | Xerosis severity scale, Tenderness Scale, VAS |
Moderate-severe bilateral xerosis | No significant difference between treatments | N/A |
| Baker and Rayman [21] | III-3 | M/F, 40 – 74 years | 26 (12) | 10% urea foam vs ‘patient’s regular creams’ (aqueous cream, Diprotobase and Unguentum) | 14 days | 5-point scale for dryness, flexibility and callus formation | Type 1 or 2 diabetes Neuropathic Bilateral xerosis |
10% urea foam superior to patient’s existing creams | Effect size −2.33) (95% CI: −2.99 to −1.59) |
| Quatrezoos et al. [19] |
III-2 | Female, 55 – 62 years | 30 (0) | Chitlin – Glucan vs placebo vehicle + glycerol | 35 days | Moisture Accumulation Test (MAT) | Menopausal women Type 1 or 2 diabetes Mod – severe xerosis |
Chitlin-Glucan superior to placebo vehicle, equal result to glycerol yet longer-lasting | Mean difference of 60 points |
| De Soca and De Atencio [18] | IV | M/F, 20 – 50 year | 40 (NR) | 10% urea cream | 28 days | Clinical scoring, VAS, Hydrometer, Skin pH |
20 – 50 yo ‘Normal’ body weight Type 1 or 2 diabetes |
Significant improvement after treatment | Mean difference of 5.4 |
| Baalham et al. [4] | III-3 | Female, age NR | 15 (0) | Paraffin vs Paraffin + 10% urea | 14 days | Digital moisture monitor | Adult Free of cutaneous disease Bilateral xerosis |
Paraffin + 10% urea superior | Effect size 0.87 (95% CI: 0.1 to 1.59) |
| Garrigue et al. [8] | III-2 | M/F, 18 – 75 years | 54 (24) | Pedimed ® (urea, lactic acid, paraffin) vs placebo vehicle | 28 days | Xerosis Assessment Score (XAS), D-Squame Corneometer |
M / F 18 – 25 Type 1 or 2 diabetes Mod – severe xerosis |
Pedimed ® superior to placebo vehicle | 18% difference between groups (P < 0.05) |
| Grossman et al. [1] | IV | M/F, 41 – 70 year | 12 (6) | 35% urea foam | 28 days | Clinical grading score, Global assessment score |
≥18 years Xerosis diagnosis as per Global Assessment Score |
Significant improvement after treatment | N/A |
| Papanas et al. [22] | III-2 | M/F, age NR | 20 (10) | 10% urea foam vs no treatment | 14 days | Corneometer | Type 2 diabetes | 10% urea foam was superior to no treatment | Effect size 1.25 (95% CI: 0.55 to 1.9) |
| Ciammaichella et al. [23] | III-2 | M/F, age NR | 54 (29) | 5% urea cream vs no treatment | 28 days | Microangiopathy, Ultrasound, Partial O2 + CO2 pressures, VAS scale |
Diabetes - Insulin treated Stable control Defined neuropathy |
5% urea cream superior to no treatment | N/A |
| Dykes [24] | III-3 | Female, 22 – 64 years | 25 (0) | 25% urea cream vs unspecified urea cream | 14 days | Clinical photo scores, Corneometer |
18+ years old Visibly dry feet Otherwise healthy |
25% urea cream more effective than unspecified urea cream | Effect size −0.26 (95% CI: −0.83 to 0.35) |
| Federici, Federici and Milani [17] | III-2 | M/F, 40 – 75 years | 40 (16) | Urea, arginine and carnosine cream vs glycerol cream | 28 days | Dryness Area Severity Index (DASI score), VAS score |
40 – 75 years Mod – severe xerosis Type 2 diabetes |
Urea, arginine and carnosine cream superior | Mean difference −0.8 |
| Loden, von Scheele and Michelsen [3] | III-3 | M/F, 21 – 86 years | 50 (25) | 15% alphahydroxy acid + 15% urea cream vs healthy controls | 14 days | Trans-epidermal water loss (TEWL), Clinical scores, VAS |
UTD | 15% alphahydroxy acid + 15% urea significantly improved skin condition in both symptomatic and healthy samples | N/A |
III-2 comparative study with concurrent controls, III-3 comparative study without concurrent controls, IV case series with either post-test or pre-test/post-test outcomes (as per [15]); NR not reported, n sample size, yrs years, UTD unable to determine, n sample size; M male; F female, VAS visual analogue scale; CI confidence interval