A monocentric study for checking the efficacy of moisturizer in improving skin dryness related with mild to moderate condition of dry, itchy and inflamed skin for a period of 4 weeks
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2023/02/049458
- Lead Sponsor
- OREAL INDIA PVT. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 117
1.Subjects 18 years of age and above.
2.Subject fulfilling the revised UK Diagnostic criteria for atopic dermatitis.
3.Subjects with mild to moderate Atopic Dermatitis (based on revised UK Diagnostic criteria) with a SCORAD score of <50, with at least 40 subjects of each grade.
4.Present or past history of Atopic Dermatitis/Atopy.
5.Subjects with clinical diagnosis of mild to severe skin xerosis over legs associated with symptoms and signs such as erythema, desquamation, pruritus/itching, lichenification etc. (as verified by the Investigator using ODS scoring (1 to 3) and SRRC Grading (1 to 3).
6.Subjects of skin phototype III, IV & V (with at least 25 subjects in each phototype) based on ITA.
7.Subjects with no diseased state or physical condition that the Investigator believes could interfere with the interpretation of the data.
8.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.
9.Subjects willing not to use any other cream/lotion/perfume/any skin care products/any other treatments on the affected areas during the study, except the investigational product and their own regular cleanser.
10.Subjects willing not to remove hair of both legs (between knee and ankle) and affected area by waxing/shaving/using stone/etc or any depilatory (hair removing) within 3 days before the scheduled study visit and otherwise to maintain hair removal practices with prior 30-day safe usage (i.e., someone who typically shaves should not begin waxing instead during the course of the study).
11.Subject willing and able to fulfil the study requirements and schedule.
12.Subject willing to provide written informed consent and are able to read, speak, write, and understand English or Hindi.
13.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 4, Day 28].
14.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.
1.Subjects with very severe atopic dermatitis.
2.Subjects with a history of allergy, anaphylaxis or hypersensitivity to any of the ingredients.
3.Subjects with a history of allergic contact dermatitis secondary to moisturizers.
4.Subjects with any clinical manifestation in the treatment area(s) or other disorders that, in the investigator’s opinion, may affect assessments or results of the study products.
5.Subjects who are unable or unwilling to attend all study visits and follow treatment regimen.
6.Subject with any systemic disorder or skin disease that would in any way confound interpretation of the study results.
7.Subject with a history of medical/surgical events that, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study.
8.Subject who is pregnant or lactating or who is planning to become pregnant during the study.
9.Subject who has been exposed to excessive or intensive UV light (natural or artificial) prior to the study and planning during the study.
10.Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship.
11.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.
12.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.
13.Subject in an exclusion period or participating in another biomedical research study (self-reported).
14.Subject who cannot be contacted by telephone in case of emergency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical efficacy and safety of investigational product in improving symptoms associated with Atopic dermatitis and skin xerosis as compared to the baseline, using the following: <br/ ><br>The extent and severity of atopic eczema (SCORing Atopic Dermatitis) by calculating SCORAD index. <br/ ><br>•The clinical scoring systems of EEMCO Guidance to evaluate visual signs of skin dryness over legs: <br/ ><br>1.Overall Dry Skin Score (ODS). <br/ ><br>2. Specified Symptom Sum Score (SRRC Grading for Scaling, Roughness, Redness & Cracks). <br/ ><br>Subject evaluation of itch/pruritus severity using the 11-point NRS itch scale. <br/ ><br>Evaluation of Skin Hydration using Corneometer CM 825®/MPA 6 over legs. <br/ ><br>Evaluation of TEWL (Trans epidermal water loss) using Tewameter TW Hex over legs. <br/ ><br> <br/ ><br>Timepoint: Day 0, 14, 28,31 and 35. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To assess the efficacy of investigational product in improving the quality of life of subjects through Dermatology life quality index (DLQI) questionnaire. <br/ ><br>2.To assess the efficacy of investigational product by subjective appreciation of the efficacy and organoleptic characteristics of the investigational product through self-assessment questionnaire. <br/ ><br>3.To assess the safety and cutaneous acceptability of the investigational product throughout the study duration (in treatment phase) by monitoring AE or/and LI. <br/ ><br>Timepoint: Day 0, 14, 28,31 and 35.