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Completed

NCT Number: NCT06678464

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.

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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.
  • 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. 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.
  • 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.

Treatment and study plan

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 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 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

Primary outcomes

  1. To evaluate the effectiveness of the test products in terms of change in skin hydration

    Time frame: 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)

    Instrumental evaluation by Corneometer CM 825

  2. To assess the effectiveness of the test products in terms of change in DASI score

    Time frame: 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)

    Using DASI Score where 0 is absent 4 is extreme

  3. To assess the effectiveness of the test products in terms of change in overall dry skin score (ODS)

    Time frame: 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)

    Using scoring scale where 0 is absent and 4 is extreme

  4. To assess the effectiveness of the test products in terms of change in PGA score

    Time frame: 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)

    Scoring scale where 0 is none and 8 is extreme

  5. To assess the effectiveness of test products in terms of change in skin barrier function

    Time frame: 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)

    Instrumental Evaluation by Tewameter TM Hex

  6. To assess the effectiveness of the test products in terms of change in skin roughness

    Time frame: 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)

    Using Scoring Scale 0 is absent and 4 is extreme

  7. To assess the effectiveness of the test products in terms of change in skin scaliness

    Time frame: 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)

    Using Scoring Scale 0 is absent and 4 is extreme

  8. To assess the effectiveness of the test products in terms of change in skin smoothness

    Time frame: 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)

    Using Scoring Scale 0 is absent and 4 is extreme

  9. To assess the effectiveness of the test products in terms of change in skin wrinkles

    Time frame: 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)

    Using Scoring Scale 0 is absent and 4 is extreme

Secondary outcomes

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

    Time frame: 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)

    using instrumental evaluation of VISIOSCAN VC 20 Plus though Corneofix® F 20

Other outcomes

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

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

  2. To assess the effectiveness of the test products in terms of change in visual assessment of skin smoothness

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

  3. To assess the effectiveness of the test products in terms of change in visual assessment of skin roughness

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

  4. To assess the effectiveness of the test products in terms of change in visual assessment of skin redness

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

  5. To assess the effectiveness of the test products in terms of change in visual assessment of skin itchiness

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

  6. To assess the effectiveness of the test products in terms of change in visual assessment of skin scaliness.

    Time frame: 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).

    Using a scoring scale where 0 is absent and 4 is extreme

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Collaborators

  • Glowderma Lab Private Limited

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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