None listed
Conditions
Interventions
Intervention1: Dew Restore Barrier Repair Cream: Test Product Name: Dew Restore Barrier Repair Cream
Product By: Kayura Effect
Dose: as required
Dosage form : semi solid
Mode of Usage: Wash the face
Sponsors
Kayura Effect LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years (both inclusive) at the time of consent. 2) Sex: Healthy male and non-pregnant/non-lactating females (Preferably equal). 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) 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 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. 8) 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. 9) Subjects are willing to give written informed consent and are willing to come for regular follow up. 10) Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study. 11) Subject who have not participated in a similar investigation in the past three months. 12) Willing to use test product throughout the study period
Exclusion criteria
Exclusion criteria: 1) 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) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti histamines, corticotherapy etc.) that might influence the outcome of the study. 5) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment. 6) 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. 7) History of alcohol or drug addiction. 8) Subjects using other marketed products during the study period. 9) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion. 10) Pregnant or breastfeeding or planning to become pregnant during the study period. 11) History of chronic illness which may influence the cutaneous state. 12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test product in terms of 1.change in DASI score from the baseline before and after usage of the test product. 2.change in overall dry skin score (ODS) from the baseline before and after usage of the test product. 3.change in PGA score from the baseline before and after usage of the test product. 4.change in skin hydration from the baseline before and after usage of the test product. 5.change in skin barrier function from the baseline before and after usage of the test product. 6.change in skin roughness, skin scaliness, skin smoothness and skin wrinkles from the baseline before and after usage of the test product. Timepoint: 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
| Measure | Time frame |
|---|---|
| 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. 2. change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness from the baseline before and after usage of the test product. 3. subject perception questionnaire after usage of the test product from baseline before and after usage of the test product. Timepoint: 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 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed