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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- To evaluate the effectiveness of the test product in terms of
Study Overview
Brief Summary
This is prospective, interventional, control-arm, evaluator-blinded, site randomized, 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 up to 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.
There are four visits in this study.
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): Product Usage Period, Evaluations
Visit 04 (Day 30): Evaluations, End of Study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
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) 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 7) 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 postmenopausal 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.
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, antihistamines, 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.
- •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.
Outcomes
Primary Outcomes
To evaluate the effectiveness of the test product in terms of
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
1.change in DASI score from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
2.change in overall dry skin score (ODS) from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
3.change in PGA score from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
4.change in skin hydration from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
5.change in skin barrier function from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
6.change in skin roughness, skin scaliness, skin smoothness and skin wrinkles from the baseline before and after usage of the test product.
Time Frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30
Secondary Outcomes
- To assess the effectiveness of the test product in terms of(1.change in desquamation index from baseline before and after usage of the test product.)
Investigators
Dr Nayan Patel
NovoBliss Research Private Limited