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Table 4 Characteristics of included studies (listed in chronological order)

From: Moisturisers for the treatment of foot xerosis: a systematic review

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

  1. 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