Dataset Information

Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream.

ABSTRACT:

Background

Ichthyosis Vulgaris (IV) is a common genetic skin disease, characterized by dry, scaling skin and itch. Urea cream has been a central part of IV treatment for decades, but only few studies have evaluated the effect of urea compared to basic moisturizers.

Objective

To evaluate the treatment effect of 7.5% urea cream compared to a basic moisturizer in patients with IV.

Methods

Participants (n = 14) were randomized to apply the 7.5% urea cream on one body half and a basic moisturizer on the other during a study period of 4 weeks. Measuring points on participants arms and legs were evaluated at baseline and at endpoint with a patient questionnaire visual assessment scale (VAS), a clinical scoring, and electronic skin hydration analysis to assess the treatment effects.

Results

On the arms, no significant differences between the two treatments were found. On the legs, however, the urea treated areas had a significantly higher decrease in SRRC score (0.7 points [95% CI: 1.1-0.3, p < 0.005]) and increase in hydration (32.1 μS [95% CI: 10.9-53.2, p < 0.006]).

Conclusion

Skin hydration improved significantly with both urea and moisturising treatment. On the legs, with most keratinization, urea was superior.Trial registry: https://clinicaltrials.gov/ct2/show/NCT02978209?cond=Ichthyosis+Vulgaris&draw=1&rank=2.

SUBMITTER: Dorf ILH

PROVIDER: S-EPMC9060062 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream.

Dorf I L H ILH Lunen M S MS Koppelhus U U

Skin health and disease 20210914 4

<h4>Background</h4>Ichthyosis Vulgaris (IV) is a common genetic skin disease, characterized by dry, scaling skin and itch. Urea cream has been a central part of IV treatment for decades, but only few studies have evaluated the effect of urea compared to basic moisturizers.<h4>Objective</h4>To evaluate the treatment effect of 7.5% urea cream compared to a basic moisturizer in patients with IV.<h4>Methods</h4>Participants (<i>n</i> = 14) were randomized to apply the 7.5% urea cream on one body hal ...[more]

PMID: 35663767

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Project description:ImportanceOnce-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.ObjectiveTo evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis.Design, setting, and participantsTwo phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively.InterventionsPatients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks.Main outcomes and measuresThe primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points).ResultsAmong 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2.Conclusions and relevanceAmong patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety.Trial registrationClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Project description:ImportancePhotoaging, which is premature skin aging caused by long-term UV exposure, is of aesthetic concern to many patients.ObjectiveTo investigate the effect of topical fluorouracil, 5%, cream on photoaging using validated photonumeric scales.Design, setting, and participantsThe Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial was a randomized clinical trial of 932 US veterans with a recent history of 2 or more keratinocyte carcinomas performed from September 30, 2011, through June 30, 2014, to assess the chemopreventive effects of a standard course of topical fluorouracil. Photographs were taken at baseline and at numerous time points for up to 4 years. In our secondary analysis, 2 independent dermatologists graded these photographs using 4 validated photonumeric scales. A total of 3042 photographs from 281 participants randomized to apply topical fluorouracil or placebo were evaluated at baseline, 6 months, 12 months, and 18 months using 4 photonumeric scales (Griffiths scale, Allergan forehead lines scale, melomental folds scale, and crow's feet scale). Data analysis was performed from November 1, 2016, to January 1, 2017.InterventionsParticipants were randomized to apply topical fluorouracil, 5%, cream or a vehicle control cream to the face and ears twice daily for 2 to 4 weeks for a total of 28 to 56 doses.Main outcomes and measuresEffect of a standard course of fluorouracil on the extent of photodamage as measured using 4 photonumeric scales.ResultsThe study population was predominantly male (274 [97.5%]) and white (281 [100%]), with a mean (SD) age of 71.5 (0.57) years. No statistically significant changes were found in photodamage between baseline and 6 months (Griffiths scale: χ2 = 0.01, P = .93; Allergan forehead lines scale: χ2 = 0.18, P = .67; melomental fold scale: χ2 = 0.03, P = .87; crow's feet scale: χ2 = 2.41, P = .12), 12 months (Griffiths scale: χ2 = 1.39, P = .24; Allergan forehead lines scale: χ2 = 0.64, P = .43; melomental fold scale: χ2 = 0.12, P = .73; crow's feet scale: χ2 = 1.07, P = .30), and 18 months (Griffiths scale: χ2 = 3.11, P = .08; Allergan forehead lines scale: χ2 = 0.89, P = .34; melomental fold scale: χ2 = 1.64, P = .20; crow's feet scale: χ2 = 0.46, P = .50).Conclusions and relevanceThis study did not demonstrate improvement in photoaging with a standard course of topical fluorouracil, 5%, cream, a finding that may be attributable to a true lack of effect in photodamage or limitations of the photonumeric scales in capturing the effect. The development of photonumeric scales that include manifestations of photoaging other than rhytids, such as lentigines, hyperpigmentation, and telangiectasias, should be considered.Trial registrationclinicaltrials.gov Identifier: NCT00847912.

Project description:IntroductionPsoriasis is estimated to affect 0.44-2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis.MethodsThis was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18-75 years who were prescribed the cream in routine clinical practice, as per clinician's discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study.ResultsThe study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths.ConclusionsThe evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis.Trial registration numberCTRI/2017/03/008023.FundingDr. Reddy's Laboratories Ltd.

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Dataset Information

Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream.

Background

Objective

Methods

Results

Conclusion

Publications

Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream.

Similar Datasets

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