A Clinical Study to Assess the Safety and Effectiveness of Test Product "Moiz Cleansing Lotion" in Healthy Adult Human Subjects With Varied Skin Types. (Dry, Oily, Sensitive, Mixed, Normal)

NCT06628258 | Completed

• 1 other identifier: NB240043-GL
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, prospective, open-label, interventional, safety in-use, tolerability and efficacy study of the test product "Moiz Cleansing Lotion" in healthy human subjects.

Conditions

All Skin Types

Outcome Measures

Primary Outcomes (2)

• change in L*, a*, b* value by using Skin Colorimeter

  To evaluate the effectiveness of the test product in terms of change in L\*, a\*, b\*

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

• change in skin impurities using Visiopor® PP34N

  To evaluate the effectiveness of the test product in terms of change in skin impurities

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

Secondary Outcomes (15)

• change in skin hydration using Corneometer CM 825

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

• change in skin barrier function using TEWAMeter

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

• change in overall dry skin score by dermatological evaluations

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

• change in PGA score by dermatological evaluations

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

• change in product perception questionnaire

  before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

Study Arms (1)

Dry, sensitive, oily, mixed, normal skin type

EXPERIMENTAL

Test Product Name: Moiz Cleansing Lotion Product By: Glowderma Lab Private Limited Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry. Frequency: Twice a Day Route of Administration: Topical.

Other: Moiz Cleansing Lotion

Interventions

Moiz Cleansing Lotion OTHER

Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry. Frequency: Twice a Day Route of Administration: Topical.

Dry, sensitive, oily, mixed, normal skin type

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 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, oily, mixed, sensitive and normal skin at a time of screening. (Dermatological Assessment)
• 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
• 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.
• 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 product.
• Subjects who have applied topical product for at least 4 weeks and any systemic product 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

• NovoBliss Research Pvt Ltd: lead
• Glowderma Lab Private Limited: collaborator

Study Sites (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

Location

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: October 4, 2024
• Study Start: October 23, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)