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. 2019 Sep;9(3):537-546.
doi: 10.1007/s13555-019-0307-0. Epub 2019 Jun 14.

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis

Hemangi Rajiv Jerajani  1 , Jayakar Thomas  2 , Alka Gupta  3 , Gurram Narasimha Rao Netha  4 , Ranju Chawla  5 , Rashid Shaikh  6 , Ravindra Babu  7 , Irene Williams  8 , Prajakta Talathi  9 , Suyog C Mehta  10 , Rajan Mittal  10 , Shivani Acharya  10 , Sujeet N Charugulla  11
Affiliations

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis

Hemangi Rajiv Jerajani et al. Dermatol Ther (Heidelb). 2019 Sep.

Abstract

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.

Keywords: Compliance; Moisturizer; Psoriasis; Quality of life; Real world; Safety.

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Conflict of interest statement

Suyog C. Mehta is a medical pharmacologist, part of the Medical Affairs team of and employee of Reddy’s Laboratories Ltd. Sujeet N. Charugulla is a medical pharmacologist, part of the Medical Affairs team and employee of Dr. Reddy’s Laboratories Ltd. Rajan Mittal is a medical pharmacologist, part of the Medical Affairs team and employee of Dr. Reddy’s Laboratories Ltd. Shivani Acharya is a medical pharmacologist, part of the Medical Affairs Team and employee of Dr. Reddy’s Laboratories Ltd. Hemangi Rajiv Jerajani received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Jayakar Thomas received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Alka Gupta received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Narasimha Rao Netha G received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Ranju Chawla received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Rashid Shaikh received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Ravindra Babu received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Irene Williams received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study. Prajakta Talathi received remuneration from Dr. Reddy’s Laboratories Ltd. for conduct of the clinical study.

Figures

Fig. 1
Fig. 1
Various topical and systemic therapies available for the management of psoriasis [6]. FAE fumaric acid ester; MTX methotrexate; PUVA psoralen + UVA treatment; UVA ultraviolet A; UVB ultraviolet B. Narrow band UVB
Fig. 2
Fig. 2
Effect of treatment with cream on DLQI scores over study period
Fig. 3
Fig. 3
Effect of treatment with cream on DASI scores over study period
See this image and copyright information in PMC

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