Skip to content

A clinical study to assess the safety and effectiveness of test product in healthy adult human subjects with dry or sensitive skin

A clinical safety, in-use tolerability and efficacy study of the test product in heathy adult human subjects with dry or sensitive skin. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084942
Enrollment
32
Registered
2025-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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:

Sponsors

SAVA Healthcare Limited
Lead Sponsor

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. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) Subject are generally in good health. 5) Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment) 6) Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds. 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) Presence of any broken, chapped, cut, irritated, or scraped skin at the application site. 5) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study. 6) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment. 7) 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. 8) 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. 11) Pregnant or breastfeeding or planning to become pregnant during the study period. 12) 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of test products in terms of change in: 1. skin hydration using corneometer CM 825 2. skin elasticity using Cutometer dual MPA 3. Dry skin using ODS scoring scale Change Dry Skin using DASI Score 4. Skin barrier function using TEWAMeter TM Hex 5. skin roughness, skin scanlines, skin smoothness, skin wrinkles using VISIOScan VC 20 plusTimepoint: Baseline on Day 1, Day 02 and Day 15

Secondary

MeasureTime frame
To evaluate the change in the effectiveness of skin itchiness and redness using VAS scoreTimepoint: Baseline on Day 1, Day 02 and Day 15;To evaluate the effectiveness of the test product in skin dryness, smoothness, roughness, redness, itchiness through 4 point scoring scaleTimepoint: Baseline on Day 1, Day 02 and Day 15;To evaluate the effectiveness of the test product in terms of questionnaire using 9 point hedonic scaleTimepoint: Baseline on Day 1, Day 02 and Day 15

Countries

India

Contacts

Public ContactDr Maheshwari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in7948983895

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026