Home > DARE Reviews > Relative efficacy and interchangeability...

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Relative efficacy and interchangeability of various clobetasol propionate vehicles in the management of steroid-responsive dermatoses

SR Feldman.

Review published: 2005.

Link to full article: [PMC free article: PMC3964525]

CRD summary

This review compared lotion and cream preparations containing clobetasol propionate for treating psoriasis and atopic dermatitis. The author concluded that a lotion is as effective as cream and emollient cream preparations, and is as well tolerated. The significant shortcomings in the review methods mean that the conclusion should be treated with caution.

Authors' objectives

The stated objective was to compare the effectiveness and tolerability of cream and lotion formulations of high-potency corticosteroids for psoriasis and atopic dermatitis. The actual objective appears to have been to compare lotion and cream formulations of clobetasol propionate.

Searching

MEDLINE and websites of unspecified dermatologic journals were searched from 1975 to November 2004; the search terms were reported.

Study selection

Study designs of evaluations included in the review

All study designs were eligible for inclusion.

Specific interventions included in the review

It appeared that studies with high-potency (class I) corticosteroid cream and/or lotion treatment arms were eligible for inclusion. Studies of clobetasol propionate were included in the review. The included studies compared 0.05% clobetasol propionate lotion with equal strength formulations in cream or emollient cream vehicle, and a lotion vehicle control group. The test product in all the included studies appeared (from the original sources) to be Clobex lotion (Galderma Laboratories). Treatment was applied twice a day for 2 to 4 weeks.

Participants included in the review

Studies in patients with psoriasis and/or atopic dermatitis were eligible for inclusion. The participants in two studies had moderate to severe plaque-type psoriasis covering at least 10% of their body surface area and a total baseline dermatologic sum score (DSS) of 6 or more on the target area. They were at least 18 years old and predominantly white. The participants in one study had moderate to severe atopic dermatitis covering at least 20% of the body surface area and a total baseline DSS of 6 or more on the target area. They were at least 12 years old. The studies included men and women.

Outcomes assessed in the review

No inclusion criteria were stated. Measures of effectiveness and tolerability appeared to be eligible. The outcomes assessed in the included studies were the Global Severity Score (GSS), DSS, global improvement score, percentage body surface area involved, individual signs of erythema, plaque elevation and scaling measured on a Likert scale (in the psoriasis studies), pruritis measured on a Likert scale (in the dermatitis study), cosmetic acceptability to the patients, and adverse events. Two studies specified the primary outcome as success rate, derived either from the GSS or the reduction in GSS from baseline, respectively. The duration of follow-up was 28 days.

How were decisions on the relevance of primary studies made?

The author did not state how the papers were selected for the review, or how many reviewers performed the selection.

Assessment of study quality

The author did not state that validity was assessed.

Data extraction

The author did not state how the data were extracted for the review, or how many reviewers performed the data extraction. Data appeared to have been extracted as reported in the original study reports, including p-values (p<0.05 indicated statistical significance).

Methods of synthesis

How were the studies combined?

The studies were summarised individually in the text with a brief narrative summary by treatment indication.

How were differences between studies investigated?

The studies were grouped by the condition treated (psoriasis or dermatitis) and some differences in study characteristics were noted in the narrative summaries.

Results of the review

Three studies were included. One was a multicentre, randomised, single-blind (investigators blinded) controlled trial (RCT) involving 222 patients. The other two studies were controlled trials involving a total of 421 patients (it appeared from the discussion section of the report that they were also multicentre RCTs, but this was not stated in the body of the review).

Psoriasis.

The effectiveness of 0.05% clobetasol propionate lotion and cream or emollient cream was similar in two studies (one unpublished) of patients with moderate to severe plaque-types psoriasis (414 patients). The patient rating of cosmetic acceptability was significantly higher (p<0.05) for lotion compared with cream in one RCT. In one study, 5 of the 82 patients treated with lotion, 2 of the 81 treated with emollient cream, and 3 of the 29 who applied lotion vehicle (control group) experienced treatment-related adverse events. In the other trial the event rates were 2 out of 94, 2 out of 95, and 0 out of 33, respectively.

Atopic dermatitis.

The effectiveness of 0.05% clobetasol propionate lotion and emollient cream was similar in one unpublished study of patients with atopic dermatitis (229 patients). Treatment-related adverse events were experienced by 4 of the 96 patients treated with lotion, 1 of the 100 treated with emollient cream, and 6 of the 33 who applied lotion vehicle in the control group.

Authors' conclusions

Clobetasol lotion, cream and emollient cream were comparable in their effectiveness and tolerability in adults with moderate to severe psoriasis or atopic dermatitis.

CRD commentary

The objectivity of this review, which was conducted by a single author, was doubtful. First, neither the review question nor the inclusion criteria were clearly reported. Second, the search to identify relevant studies was very limited and there was no indication that steps were taken to minimise bias in the selection of studies for inclusion. Finally, although the funding source for the review was declared, the report did not make clear the association between the sponsor and the product tested in the three included studies. The quality of the included studies was not assessed systematically and the study design characteristics were not reported in sufficient detail to allow independent judgment of the potential for bias in the individual studies. Furthermore, the data extraction process was not described and the potential for outcome-reporting bias in the review is unknown. The conclusions must be regarded with caution given the lack of information to judge the impartiality of the review, the robustness of the methods and the reliability of the results.

Implications of the review for practice and research

Practice: The author did not state any implications for practice, other than that patients prefer less messy vehicles such as lotions.

Research: The author stated that further comparative studies of lotions and creams are needed to determine the impact of the vehicle on compliance.

Funding

Galderma Laboratories, Texas.

Bibliographic details

Feldman S R. Relative efficacy and interchangeability of various clobetasol propionate vehicles in the management of steroid-responsive dermatoses. Current Therapeutic Research 2005; 66(3): 154-171. [PMC free article: PMC3964525] [PubMed: 24672120]

Indexing Status

Subject indexing assigned by CRD

MeSH

Administration, Topical; Anti-Inflammatory Agents /administration & dosage; Clobetasol /administration & dosage /therapeutic use; Dermatitis /drug therapy; Dermatologic Agents /administration & dosage /therapeutic use; Ointments; Psoriasis /drug therapy; Skin Diseases /drug therapy

AccessionNumber

12005002279

Database entry date

31/07/2007

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 24672120

Download

PubMed Health Blog...

read all...

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...