A Monocentric, Assesor Blind, Randomized, Controlled, Before And After Use Clinical Study To Evaluate And Compare The Efficacy Of Topically Applied Moisturizer In Improving Symptoms Associated With Cutaneous Xerosis On The Legs, Over A Period Of 4 Weeks
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate and compare the moisturizing efficacy and safety of the investigational product in improving the symptoms associated with cutaneous xerosis, in comparison to the baseline and non-treated control site, using the following:
研究概览
简要总结
The study aims at evaluating and comparing the moisturizing efficacy and safety of the Excela Max Moisturiser in
improving the symptoms associated with cutaneous xerosis, in comparison to the baseline and nontreated
control site, using the following:
- The clinical scoring systems of EEMCO Guidance to evaluate visual signs of skin dryness:
➢ Overall Dry Skin Score (ODS).
➢ Specified Symptom Sum Score (SRRC Grading for Scaling, Roughness,
Redness & Cracks).
-
Subject evaluation of itch/pruritus severity using the 11-point NRS itch scale.
-
Evaluation of Skin Hydration using Corneometer CM 825®/MPA.
-
Evaluation of TEWL (Trans epidermal water loss) using Tewameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with clinical diagnosis of skin xerosis associated with symptoms and signs such as erythema, desquamation, pruritus/itching, lichenification etc.
- •(as verified by the Investigator using ODS scoring and SRRC Grading) 2.Subjects between 18-65 years (both inclusive) of age.
- •3.Subjects with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •4.Subjects free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions that as per the investigator could interfere with interpretation of the data.
- •5.Subjects willing not to use any other soap/cleanser/cream/lotion/perfume/any skin care products/any other treatments on the affected area during the study, except investigational product and their own regular cleanser.
- •6.Subjects willing not to remove hair of the affected area by waxing/shaving/using stone/etc or any depilatory (hair removing) within 3 days before the scheduled study visit.
- •7.Subject willing and able to fulfil the study requirements and schedule 8.Subject willing to provide written informed consent and are able to read, speak, write, and understand English or Hindi or any other vernacular language.
- •9.Female of childbearing potential willing to undergo urine pregnancy test [self-declared by subject on screening visit and test to be done on Visit 2, Baseline visit (Day 0) and Visit 6, Day 28] 10.Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study.
排除标准
- •1.Subjects who are pregnant or lactating or who are planning to become pregnant during the study.
- •2.Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study.
- •3.Subjects having known hypersensitivity to the study product or its constituents.
- •4.Any significant medical condition that would interfere with the participation in the trial, as per opinion of the Investigator.
- •5.Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator.
- •6.Any topical or systemic treatment which in the opinion of the investigator might counter or influence the trial aim within the last 4 weeks prior to participation in the study and during the study.
- •7.Subjects with any of the following conditions present on the test area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, ulcers and wounds.
- •8.Having participated in the last 30 days before screening or currently participating in another clinical study.
- •9.Unable to be contacted by phone in case of emergency.
结局指标
主要结局
To evaluate and compare the moisturizing efficacy and safety of the investigational product in improving the symptoms associated with cutaneous xerosis, in comparison to the baseline and non-treated control site, using the following:
时间窗: Day 1 7 14 and 28
3. Evaluation of Skin Hydration using Corneometer CM 825®/MPA.
时间窗: Day 1 7 14 and 28
1. The clinical scoring systems of EEMCO Guidance to evaluate visual signs of skin dryness:
时间窗: Day 1 7 14 and 28
➢ Overall Dry Skin Score (ODS).
时间窗: Day 1 7 14 and 28
➢ Specified Symptom Sum Score (SRRC Grading for Scaling, Roughness, Redness & Cracks).
时间窗: Day 1 7 14 and 28
2. Subject evaluation of itch/pruritus severity using the 11-point NRS itch scale.
时间窗: Day 1 7 14 and 28
4. Evaluation of TEWL (Trans epidermal water loss) using Tewameter.
时间窗: Day 1 7 14 and 28
次要结局
- Self-Assessment Questionnaire at Day 1, Day 7, Day 14 & Day 28 as compared to Day 0.(• Safety will be assessed by recording adverse events, including cutaneous reactions related to the investigational products (cutaneous acceptability) throughout the study duration (in treatment phase).)