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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
84 participants
Study completion date
February 18, 2025
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Related Scientific Literature
Loading related publications...
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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).
+3 more other outcomes
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
Interventions
Moiz MMOther
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 XLOther
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
Eligibility Criteria
Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.
84 participants (actual enrollment reported by the registry).
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
Actual (reported)
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
Moiz XL
Moiz LMF 48Other
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
\) 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.
Contact the study team to confirm eligibility.
Primary Completion
February 18, 2025
Actual (reported)
Study Completion
February 18, 2025
Actual (reported)
Last Updated
March 3, 2025
Record last verified: 2025-02
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.