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A Consumer Research Study to Evaluate the moisturization properties of Test Products in Healthy Adult & Adolescent Human Subjects

A Single Center, Application Site Randomized, Evaluator-Blinded, Moisturization Study to Evaluate the moisturization properties of Test Products in Healthy Adult & Adolescent Human Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033909
Enrollment
32
Registered
2021-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Moisturizer A: White Color Lotion with characteristic odour
single dose
topical Intervention2: Moisturizer B: White Color Lotion with characteristic odour
topical Intervention3: Moisturizer C: White Color Lotion with characteristic odour
topical Intervention4: Moisturizer D: White Color Lotion with characteristic odour
topical Intervention5: Moisturizer E: Off White to White Color beads suspended into opaque gel
topical Control Intervention1: Not applicable: Not applicable

Sponsors

Zydus Wellness Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Adults subjects between ages of 18 to 30 (both inclusive) years old and in the age range from 13 to 17 Years (inclusive of both genders) at the time of consent. 2) Subject general in good health as determined from a recent medical history. 3) Subject is willing to participate in the study, give a voluntary written informed consent OR an assent and consent of the respective Legal guardian in case of adolescent subjects. 4) Subjects willing to abide by and comply with the study protocol. 5) Subjects should not participate in any other clinical study during participation in the current study

Exclusion criteria

Exclusion criteria: 1) Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period. 2) Chronic illness which may influence the cutaneous state. 3) Subjects on any systemic medication. 4) Subject with history of diabetes 5) Subjects participating in a similar clinical study, currently or during the previous 30 days. 6) Any Subjects, in the Investigator opinion not considered suitable for enrollment. 7) A known history or present condition of allergic response to any other concern that may require medical attention. 8) Adults with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.

Design outcomes

Primary

MeasureTime frame
1. To assess the effect of test product(s) on skin moisture i.e. hydration state of the skin change from baseline 2. To assess the effect of test product(s) on skin barrier function 3. To assess the effect of test product(s) on skin physical parameter using 5-point scoring scale for skin dryness, skin roughness, skin suppleness and softness, skin redness/erythema, burning, itching and stinging from baseline Timepoint: 1. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours 2. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours 3. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours

Secondary

MeasureTime frame
1 To assess Product response index (perception about product) after applicationTimepoint: 1 On Day 3

Countries

India

Contacts

Public ContactMs Maheshvari Patel

Cliantha Research

nkpatel@cliantha.com9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026