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A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry or Sensitive Skin
Condition(s) studied
Dry SkinSensitive Skin
Investigational drug(s) / intervention(s)
Creanz Lotion
Creanz Lotion: Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin.
Frequency: Twice a Day Route of Administration: Topical
Study summary
This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or sensitive skin.
Eligibility
Inclusion Criteria:
* Age: 18 to 55 years (both inclusive) at the time of consent.
* Sex: Healthy male and non-pregnant/non-lactating females.
* Females of childbearing potential must have a self-reported negative pregnancy test.
* Subject are generally in good health.
* Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment)
* Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds.
* 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.
* Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.
* 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.
Primary outcome measure(s)
- Change in skin hydration — 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, and Day 15 (+2 Days)
Instrumental Assessment: Corneometer CM 825
- Change in skin elasticity — 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, and Day 15 (+2 Days)
Instrumental Assessment: Cutometer Dual MPA 580
- Change in Dry skin area and severity index — 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, and Day 15 (+2 Days)
Dermatological assessment: 0 = Absent; 4 = Severe
- Change in Overall Dry skin Score — 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, and Day 15 (+2 Days)
Dermatological assessment: 0 = Absent; 4 = Dominated by large scales
- Change in skin barrier function — 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, and Day 15 (+2 Days)
Instrumental Assessment: TEWAMeter TM Hex
- Change in skin roughness — 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, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
- Change in skin scaliness — 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, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
- Change in skin smoothness — 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, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
- Change in skin wrinkles — 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, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
Trial sites (1)
| Facility | City | Region | Status |
| NovoBliss Research Pvt.Ltd |
Ahmedabad |
Gujarat |
|