A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry or Sensitive Skin

NCT06929988 | Not Yet Recruiting

• 1 other identifier: NB250005-SG
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Skin; Sensitive Skin

Outcome Measures

Primary Outcomes (9)

• Change in skin hydration

  Instrumental Assessment: Corneometer CM 825

  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)

• Change in skin elasticity

  Instrumental Assessment: Cutometer Dual MPA 580

  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)

• Change in Dry skin area and severity index

  Dermatological assessment: 0 = Absent; 4 = Severe

  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)

• Change in Overall Dry skin Score

  Dermatological assessment: 0 = Absent; 4 = Dominated by large scales

  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)

• Change in skin barrier function

  Instrumental Assessment: TEWAMeter TM Hex

  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)

• Change in skin roughness

  Instrumental Assessment: VISIOSCAN VC 20 Plus

  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)

• Change in skin scaliness

  Instrumental Assessment: VISIOSCAN VC 20 Plus

  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)

• Change in skin smoothness

  Instrumental Assessment: VISIOSCAN VC 20 Plus

  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)

• Change in skin wrinkles

  Instrumental Assessment: VISIOSCAN VC 20 Plus

  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)

Secondary Outcomes (8)

• Change in itchiness 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)

• change in visual assessment of skin dryness,

  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)

• Change in visual assessment of 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)

• Change in visual assessment of 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)

• Change in visual assessment of 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)

Study Arms (1)

Creanz Lotion

EXPERIMENTAL

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

Other: Creanz Lotion

Interventions

Creanz Lotion OTHER

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

Creanz Lotion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SAVA Healthcare Limited: lead

Study Sites (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382421, India

Location

Study Officials

• Nayan Patel, MBBS

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013286; dr.nayan@novobliss.in

Sheetal J Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Test Product A: 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 Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)