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A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis
INTRODUCTION: Psoriasis 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-...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6704203/ https://www.ncbi.nlm.nih.gov/pubmed/31201712 http://dx.doi.org/10.1007/s13555-019-0307-0 |
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author | Jerajani, Hemangi Rajiv Thomas, Jayakar Gupta, Alka Netha, Gurram Narasimha Rao Chawla, Ranju Shaikh, Rashid Babu, Ravindra Williams, Irene Talathi, Prajakta Mehta, Suyog C. Mittal, Rajan Acharya, Shivani Charugulla, Sujeet N. |
author_facet | Jerajani, Hemangi Rajiv Thomas, Jayakar Gupta, Alka Netha, Gurram Narasimha Rao Chawla, Ranju Shaikh, Rashid Babu, Ravindra Williams, Irene Talathi, Prajakta Mehta, Suyog C. Mittal, Rajan Acharya, Shivani Charugulla, Sujeet N. |
author_sort | Jerajani, Hemangi Rajiv |
collection | PubMed |
description | INTRODUCTION: Psoriasis 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. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: The 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 NUMBER: CTRI/2017/03/008023. FUNDING: Dr. Reddy’s Laboratories Ltd. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13555-019-0307-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6704203 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-67042032019-09-02 A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis Jerajani, Hemangi Rajiv Thomas, Jayakar Gupta, Alka Netha, Gurram Narasimha Rao Chawla, Ranju Shaikh, Rashid Babu, Ravindra Williams, Irene Talathi, Prajakta Mehta, Suyog C. Mittal, Rajan Acharya, Shivani Charugulla, Sujeet N. Dermatol Ther (Heidelb) Original Research INTRODUCTION: Psoriasis 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. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: The 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 NUMBER: CTRI/2017/03/008023. FUNDING: Dr. Reddy’s Laboratories Ltd. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13555-019-0307-0) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-06-14 /pmc/articles/PMC6704203/ /pubmed/31201712 http://dx.doi.org/10.1007/s13555-019-0307-0 Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Jerajani, Hemangi Rajiv Thomas, Jayakar Gupta, Alka Netha, Gurram Narasimha Rao Chawla, Ranju Shaikh, Rashid Babu, Ravindra Williams, Irene Talathi, Prajakta Mehta, Suyog C. Mittal, Rajan Acharya, Shivani Charugulla, Sujeet N. A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title | A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title_full | A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title_fullStr | A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title_full_unstemmed | A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title_short | A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis |
title_sort | real-world, non-interventional indian study evaluating intensive plant-based butter moisturizing cream in psoriasis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6704203/ https://www.ncbi.nlm.nih.gov/pubmed/31201712 http://dx.doi.org/10.1007/s13555-019-0307-0 |
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