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All Skin TypesNCT06628258

A Clinical Study to Assess the Safety and Effectiveness of Test Product "Moiz Cleansing Lotion" in Healthy Adult Human Subjects With Varied Skin Types. (Dry, Oily, Sensitive, Mixed, Normal)

A study testing Moiz Cleansing Lotion in people with All Skin Types, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an exploratory, prospective, open-label, interventional, safety in-use, tolerability and efficacy study of the test product "Moiz Cleansing Lotion" in healthy human subjects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
All Skin Types
What is being tested?
Moiz Cleansing Lotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteIndia
Study dates
23 Oct 2024to 4 Dec 2024
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 65 years (both inclusive) at the time of consent.
  • Sex: Healthy male and non-pregnant/non-lactating females (Preferably equal).
  • Females of childbearing potential must have a self-reported negative pregnancy test.
  • Subject are generally in good health.
  • Subject with dry, oily, mixed, sensitive and normal skin at a time of screening. (Dermatological Assessment)
  • 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
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  • 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.

Who cannot join

  • History of any dermatological condition of the skin diseases.
  • Subject with present condition of allergic response to any cosmetic product.
  • Subject having allergic response to the ink.
  • 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 product.
  • Subjects who have applied topical product for at least 4 weeks and any systemic product for at least 3 months, before they participated in the study.
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  • History of alcohol or drug addiction.
  • Subjects using other marketed products during the study period.
  • 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.
  • 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.

India1 site
  • NovoBliss Research Pvt.Ltd

    Ahmedabad, Gujarat, 382481

Other trials in India

About this study

Official title: An Exploratory, Prospective, Open-Label, Interventional, Safety In-Use, Tolerability and Efficacy Study of Test Product "Moiz Cleansing Lotion" in Healthy Human Subjects.

This is an exploratory, prospective, open-label, interventional, safety in-use, tolerability and efficacy study of the test product "Moiz Cleansing Lotion" in healthy human subjects.

Read the detailed description

27 subjects with different skin type (dry/ oily/ sensitive/ mixed/) of either gender aged between 18 to 65 years old (both inclusive) at time consent will be enrolled to complete 25 subjects/test product in 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. The adult female subjects will be instructed to visit the facility as per the below visits-

  • Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation.
  • Visit 02 (Day 15 +2 Days): Product Usage Period, Evaluations
  • Visit 03 (Day 30 +2 Days): Evaluations, End of Study
Conditions
All Skin Types
Being tested
Moiz Cleansing Lotion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moiz Cleansing LotionOther

    Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry.

    Frequency: Twice a Day Route of Administration: Topical.

Study groups in NCT06628258
Study groupRoleWhat they receive
Dry, sensitive, oily, mixed, normal skin typeExperimentalTest Product Name: Moiz Cleansing Lotion Product By: Glowderma Lab Private Limited Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry. Frequency: Twice a Day Route of Administration: Topical.
Receives: Other: Moiz Cleansing Lotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in L*, a*, b* value by using Skin Colorimeter

    To evaluate the effectiveness of the test product in terms of change in L*, a*, b*

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  2. change in skin impurities using Visiopor® PP34N

    To evaluate the effectiveness of the test product in terms of change in skin impurities

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

Secondary outcomes (15)
  1. change in skin hydration using Corneometer CM 825

    To evaluate the effectiveness of the test product in terms of change in skin hydration

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  2. change in skin barrier function using TEWAMeter

    To evaluate the effectiveness of the test product in terms of change in skin barrier function

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  3. change in overall dry skin score by dermatological evaluations

    To evaluate the effectiveness of the test product in terms of change in overall dry skin score where, 0: means absent and 4 means: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  4. change in PGA score by dermatological evaluations

    To evaluate the effectiveness of the test product in terms of change in PGA score where 0 means: No appearance and 8 means: Severe

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  5. change in product perception questionnaire

    1. To evaluate the effectiveness of the test product in terms of change in product perception questionnaire where 0 means: Dislike extremely and 9 means liked extremly

    Measured: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.

  6. change in visual and tactile assessment of scaliness

    To evaluate the effectiveness of the test product in terms of change in scaliness where 0 means: Absent and 4 means: Extreme

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  7. change in visual and tactile assessment of roughness

    To evaluate the effectiveness of the test product in terms of change in roughness where 0 means: Absent and 4 means: Extreme

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  8. change in visual and tactile assessment of redness

    To evaluate the effectiveness of the test product in terms of change in redness where 0 means: Absent and 4 means: Extreme

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  9. change in visual and tactile assessment of itchiness

    To evaluate the effectiveness of the test product in terms of change in itchiness where 0 means: None and 4 means: Severe

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  10. change in visual and tactile assessment of dryness

    To evaluate the effectiveness of the test product in terms of change in dryness where 0 means: No Skin Dryness and 4 means: Extreme Xerosis

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  11. change in visual and tactile assessment of smoothness

    To evaluate the effectiveness of the test product in terms of change in smoothness where 0 means: Very rough and 4 means: Very smooth

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  12. change in skin irritation

    Safety of test product will be evaluated in terms of change in skin irritation by dermatological assessment

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  13. change in dryness

    Safety of test product will be evaluated in terms of change in dryness by dermatological assessment

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  14. change in breakouts

    Safety of test product will be evaluated in terms of change in breakouts by dermatological assessment

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

  15. change in allergic reactions

    Safety of test product will be evaluated in terms of change in allergical reactions by dermatological assessment

    Measured: before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start23 Oct 2024
  3. Primary completion4 Dec 2024
  4. Study completion4 Dec 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628258
Sponsor's protocol ID
NB240043-GL
Status last verified
Feb 2025
First submitted
14 Sep 2024
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Moiz Cleansing Lotion in people with All Skin Types, 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 12 inclusion and 12 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?

change in L*, a*, b* value by using Skin Colorimeter (time frame: before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30.). The study lists 2 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.

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