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

NCT06678464 | Completed

• 1 other identifier: NB240044-GL
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry and Sensitive Skin

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• To assess the effectiveness of the test product in terms of change in desquamation index

  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 Outcomes (6)

• To assess the effectiveness of the test products in terms of change in visual assessment of skin dryness

  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

  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

  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).

Study Arms (3)

Moiz MM

EXPERIMENTAL

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

Moiz XL

EXPERIMENTAL

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

Moiz LMF 48

EXPERIMENTAL

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

Interventions

Moiz MM OTHER

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

Moiz MM

Moiz XL OTHER

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

Moiz XL

Moiz LMF 48 OTHER

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

Moiz LMF 48

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. 2) Sex: Healthy male and non-pregnant/non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test.
• \) 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.
• \) 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. 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.
• \) 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.
• \) Pregnant or breastfeeding or planning to become pregnant during the study period.
• \) 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.

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: December 7, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

IN (1)