Clinical trial NCT06628258: 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)
Official title: An Exploratory, Prospective, Open-Label, Interventional, Safety In-Use, Tolerability and Efficacy Study of Test Product "Moiz Cleansing Lotion" in Healthy Human Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Skin Types
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Glowderma Lab Private Limited
First posted: 2024-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 27 subjects with different skin type (dry/ oily/ sensitive/ mixed/) of either gender aged between 18 to 65 years old (both inclusive) at time consent will be enrolled to complete 25 subjects/test product in the study.

The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult female subjects will be instructed to visit the facility as per the below visits-

* Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation.
* Visit 02 (Day 15 +2 Days): Product Usage Period, Evaluations
* Visit 03 (Day 30 +2 Days): Evaluations, End of Study

Eligibility criteria: Inclusion Criteria:

* 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.

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.
* 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.
* 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 outcomes:
measure: change in L*, a*, b* value by using Skin Colorimeter
timeFrame: 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.
measure: change in skin impurities using Visiopor® PP34N
timeFrame: 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:
measure: change in skin hydration using Corneometer CM 825
timeFrame: 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.
measure: change in skin barrier function using TEWAMeter
timeFrame: 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.
measure: change in overall dry skin score by dermatological evaluations
timeFrame: 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.
measure: change in PGA score by dermatological evaluations
timeFrame: 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.
measure: change in product perception questionnaire
timeFrame: 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.
measure: change in visual and tactile assessment of scaliness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in visual and tactile assessment of roughness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in visual and tactile assessment of redness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in visual and tactile assessment of itchiness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in visual and tactile assessment of dryness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in visual and tactile assessment of smoothness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in skin irritation
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in dryness
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in breakouts
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
measure: change in allergic reactions
timeFrame: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: NovoBliss Research Pvt.Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: