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

An Exploratory, Prospective, Open-label, Randomized, Three-arm, Single-centre, Safety, Efficacy and In-use Tolerability Study of the Three Different Test Products in Healthy Adult Human Subjects With Dry and Sensitive Skin.

An exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.

This exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.

Study Overview

• Status: Completed
• Conditions: Dry and Sensitive Skin
• Intervention / Treatment: Other: Moiz MM; Other: Moiz XL; Other: Moiz LMF 48

Detailed Description

A total of up to 84 (28 subjects/arm) healthy male and non-pregnant | non-lactating female with equal distribution of dry and sensitive skin (1:1) with an age of 18-55 years will be enrolled to complete the 75 subjects (25 subjects/arm) 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.

Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation

• Visit 02 (Day 08 +2 Days): Evaluations, Product usage period
• Visit 03 (Day 30 +2 Days): Product Usage Period, Evaluations
• Visit 04 (Day 60 +2 Days): Evaluations, End of Study

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmadabad, Gujarat, India, 382481
      • NovoBliss Research Pvt.Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 and sensitive skin at a time of screening. (Dermatological Assessment) 6) 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.

  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:

• 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) any areas of broken/chapped/cut/irritated/scraped skin. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moiz MM; 1. Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical	Other: Moiz MM; Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical
Experimental: Moiz XL; Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical	Other: Moiz XL; Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical
Experimental: Moiz LMF 48; Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day or as often as needed Route of Administration: Topical	Other: Moiz LMF 48; Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day or as often as needed Route of Administration: Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effectiveness of the test products in terms of change in skin hydration	Instrumental evaluation by Corneometer CM 825	before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in DASI score	Using DASI Score where 0 is absent 4 is extreme	before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in overall dry skin score (ODS)	Using scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in PGA score	Scoring scale where 0 is none and 8 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of test products in terms of change in skin barrier function	Instrumental Evaluation by Tewameter TM Hex	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin roughness	Using Scoring Scale 0 is absent and 4 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin scaliness	Using Scoring Scale 0 is absent and 4 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin smoothness	Using Scoring Scale 0 is absent and 4 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin wrinkles	Using Scoring Scale 0 is absent and 4 is extreme	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effectiveness of the test product in terms of change in desquamation index	using instrumental evaluation of VISIOSCAN VC 20 Plus though Corneofix® F 20	before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effectiveness of the test products in terms of change in visual assessment of skin dryness	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).
To assess the effectiveness of the test products in terms of change in visual assessment of skin smoothness	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).
To assess the effectiveness of the test products in terms of change in visual assessment of skin roughness	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).
To assess the effectiveness of the test products in terms of change in visual assessment of skin redness	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).
To assess the effectiveness of the test products in terms of change in visual assessment of skin itchiness	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).
To assess the effectiveness of the test products in terms of change in visual assessment of skin scaliness.	Using a scoring scale where 0 is absent and 4 is extreme	before usage of the test products on Day 01, after usage of the test products at T20 min on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days).

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Collaborators: Glowderma Lab Private Limited
• Investigators: Principal Investigator: Dr. Nayan K Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: NB240044-GL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No