A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry and Sensitive Skin.

NovoBliss Research Pvt Ltd27 enrolled

Overview

A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study of Test Product "Dew Restore Barrier Repair Cream" in healthy adult human subjects with dry and sensitive skin.

A total of 27 Subjects will be enrolled to complete 25 Subjects the study. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult female subjects will be instructed to visit the facility as per the below visits. * Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation * Visit 02 (Day 02): Evaluations, Product usage period * Visit 03 (Day 15 +2 Days): Product Usage Period, Evaluations * Visit 04 (Day 30 +2 Days): Evaluations, End of Study

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Dry Skin Sensitive Skin

Interventions

Dew Restore Barrier Repair CreamOTHER

Wash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel\| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed. Frequency: Twice a Day Route of Administration: Topical

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 to 55 years (both inclusive) at the time of consent. * Sex: Healthy male and non-pregnant/non-lactating females (Preferably equal). * Females of childbearing potential must have a self-reported negative pregnancy test. * Subject are generally in good health. * Subject with dry and sensitive skin at a time of screening. (Dermatological Assessment) * Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites * Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. * If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. * Subjects are willing to give written informed consent and are willing to come for regular follow up. * Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study. * Subject who have not participated in a similar investigation in the past three months. * Willing to use test product throughout the study period. Exclusion Criteria: * History of any dermatological condition of the skin diseases. * Subject with present condition of allergic response to any cosmetic product. * Subject having allergic response to the ink. * Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study. * Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment. * Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study. * History of alcohol or drug addiction. * Subjects using other marketed products during the study period. * Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. * Pregnant or breastfeeding or planning to become pregnant during the study period. * History of chronic illness which may influence the cutaneous state. * Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

Locations (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

Change in DASI Score (Dry Skin/ichthyosis area and severity index). In scoring scale 0 indicates none and 4 indicates extreme.

1\. To evaluate the effectiveness of the test product in terms of change in DASI score from the baseline before and after usage of the test product.

Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).

Change in Dry Skin Score. In scoring scale 0 indicates absent and 4 indicates Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.

2\. To evaluate the effectiveness of the test product in terms of change in overall dry skin score (ODS) from the baseline before and after usage of the test product.

Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).

Change in PGA Score. In scoring scale 0 means No appearance and 7-9 means severe.

3\. To evaluate the effectiveness of the test product in terms of change in PGA score from the baseline before and after usage of the test product.

Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).

Change in Skin Hydration

4\. To evaluate the effectiveness of the test product t in terms of change in skin hydration from the baseline before and after usage of the test product.

Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).

Change in Skin Barrier Function

5\. To evaluate the effectiveness of the test product in terms of change in skin barrier function from the baseline before and after usage of the test product.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in desquamation index

1\. To assess the effectiveness of the test product in terms of change in desquamation index from baseline before and after usage of the test product.