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Loden, M, Andersson, A. C, Anderson, C, Bergbrant, I. M, Frodin, T, Ohman, H, Sandstrom, M. H, Sarnhult, T, Voog, E, Stenberg, B, Pawlik, E, Preisler-Haggqvist, A, Svensson, A, Lindberg, M. A double-blind study comparing the effect of glycerin and urea on dry, eczematous skin in atopic patients. Acta Dermato-Venereologica, 2002, 82 p.45-7 

Title

A Double-Blind Study Comparing the Effect of Glycerin and Urea on Dry, Eczematous Skin in Atopic Patients

Journal

Acta Dermato-Venereologica

Authors

Loden

Year

2002

Intervention A

Glycerin cream

Intervention A Schedule

To use as much as cream as desired and at least once daily for 30 days.

Intervention A Dose

20%

Intervention B

Urea cream

Intervention B Schedule

To use as much as cream as desired and at least once daily for 30 days.

Intervention B dose

4%

Intervention C

Placebo cream

Intervention C Schedule

To use as much as cream as desired and at least once daily for 30 days.

Intervention C dose

N/A

Comments on Interventions

participants were allowed to continue to use topical corticosteroids, but to note the use in their diary.

Is the trial randomised

Yes

Is the trial blinded

Yes

Country

Not stated

Single or multicentre trial

Not stated.

Type of trial

Not stated

Number of participants randomised

197 participants randomised. 68 = Glycerin Group, 63 = Urea Group and 66 = Placebo Group

Follow up

A dermatologist assessed the participants at inclusion and at the end of the study. The participants recorded information in a diary throughout the study.

Inclusion criteria

Atopic dermatitis.

Exclusion criteria

None had a known allergy to ingredients in the test creams.

Description of randomisation and allocation concealment

No details stated. Allocation concealment not stated.

Description of blinding

The parties blinded were not stated.

Intention to treat

Not stated.

Withdrawals/dropouts

Not stated.

Outcome A

participant assessed degree of smarting, stinging, itching, and dryness/irritation on a 5 point scale (0 to 4) after 2 weeks of treatment.

Outcome B

participant assessed skin dryness at the end of treatment (14cm visual analogue scale).

Outcome C

Dermatologist assessed dry skin (DASI, Dry skin Area and Severity Index, scaling, roughness, redness and cracks (fissures) in the worst affected area in each of 4 body regions scored 0 to 4, size of area involved was estimated. The sum severity score x % area affected = DASI (max 1600))

Main reported results

Adverse skin reactions such as smarting were felt significantly less among participants using glycerin cream compared to the urea cream (10% severe or moderate smarting vs 24%, p < 0.0006). No differences were found regarding skin reactions such as stinging, itching and dryness/irritation. The study showed equal effects on skin dryness as judged by the participants and the dermatologist.

Author's Conclusions

Our study showed that glycerin cream has a similar clinical effect as urea cream according to participants and dermatologists. Glycerin cream is demonstrated to have good skin tolerability on atopic dry skin. The study suggests that the glycerin cream may have an advantage for atopic participants owing to its lower incidence and degree of smarting than the urea cream in combination with a similar effect on skin dryness.

Quality of reporting

No details were given about method of randomisation were given. Allocation concealment and intention-to-treat were not reported.

Sponsorship and conflicts of interest

The study was sponsored by Aco Hud AB, Stockholm, Sweden.

Adverse Events

Specific adverse reactions of smarting, stinging, itching and dryness/irritation were recorded outcomes of the study. No further information on adverse events was stated.

GREAT database categories

Other comparators /Placebo; Other topical agents /Emollients

Search run Saturday 23rd of March 2019 (GREAT database last updated on Wednesday 27th of September 2017)
Please cite the GREAT database as:
The Global Resource of Eczema Trials. Centre of Evidence Based Dermatology. Accessed at http://www.greatdatabase.org.uk on ....