Dry and Sensitive SkinNCT06678464
A Clinical Study to Assess the Safety and Effectiveness of Test Products in Healthy Adult Human Subjects With Dry and Sensitive Skin.
A study testing Moiz MM, Moiz XL and Moiz LMF 48 in people with Dry and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry and Sensitive Skin
- What is being tested?
- Moiz MM, Moiz XL and Moiz LMF 48
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 7 Dec 2024to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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
- Conditions
- Dry and Sensitive Skin
- Being tested
- Moiz MM, Moiz XL, Moiz LMF 48
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Moiz LMF 48 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of the test products in terms of change in skin hydration
Instrumental evaluation by Corneometer CM 825
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
using instrumental evaluation of VISIOSCAN VC 20 Plus though Corneofix® F 20
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start7 Dec 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry and Sensitive SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Glowderma Lab Private Limited
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678464
- Sponsor's protocol ID
- NB240044-GL
- Status last verified
- Feb 2025
- First submitted
- 6 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06678464
- Acronym / sponsor ID
- NB240044-GL
- Conditions
- Dry and Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Glowderma Lab Private Limited
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moiz MM | Experimental | Other: Moiz MM1. 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 | Experimental | Other: Moiz XLMode 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 | Experimental | Other: Moiz LMF 48Mode 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moiz MMMode 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 XLMode 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 48Mode 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 |
Primary outcome
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
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
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
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
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
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
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
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
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moiz MM, Moiz XL and Moiz LMF 48 in people with Dry and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.