An Exploratory, Prospective, Open-label, Randomized, Three-arm, Single-centre, Safety, Efficacy and In-use Tolerability Study of the Three Different Test Products in Healthy Adult Human Subjects With Dry and Sensitive Skin.

NovoBliss Research Pvt Ltd1 site in 1 country84 target enrollmentDecember 7, 2024

ConditionsDry and Sensitive Skin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry and Sensitive Skin
Sponsor: NovoBliss Research Pvt Ltd
Enrollment: 84
Locations: 1
Primary Endpoint: To evaluate the effectiveness of the test products in terms of change in skin hydration
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.

This exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.

Detailed Description

A total of up to 84 (28 subjects/arm) healthy male and non-pregnant \| non-lactating female with equal distribution of dry and sensitive skin (1:1) with an age of 18-55 years will be enrolled to complete the 75 subjects (25 subjects/arm) 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. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation * Visit 02 (Day 08 +2 Days): Evaluations, Product usage period * Visit 03 (Day 30 +2 Days): Product Usage Period, Evaluations * Visit 04 (Day 60 +2 Days): Evaluations, End of Study

Registry

clinicaltrials.gov

Start Date

December 7, 2024

End Date

February 18, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NovoBliss Research Pvt Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18 to 55 years (both inclusive) at the time of consent. 2) Sex: Healthy male and non-pregnant/non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test.
•Subject are generally in good health. 5) Subject with dry and sensitive skin at a time of screening. (Dermatological Assessment) 6) 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. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subject having allergic response to the ink. 4) any areas of broken/chapped/cut/irritated/scraped skin. 5) 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. 9) Subjects using other marketed products during the study period. 10) 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. 13) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

Outcomes

Primary Outcomes

To evaluate the effectiveness of the test products in terms of change in skin hydration

Time Frame: before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)

Instrumental evaluation by Corneometer CM 825

To assess the effectiveness of the test products in terms of change in DASI score

Time Frame: before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)

Using DASI Score where 0 is absent 4 is extreme

To assess the effectiveness of the test products in terms of change in overall dry skin score (ODS)