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Effect of serum in helathy humans

Efficacy and Sensory Evaluation of Face Serum in Conferring Hydration benefits in Healthy Human Volunteers - None

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034980
Enrollment
45
Registered
2021-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Face Serum (ITC-HS07-2021): One or Two pumps of serum will be applied Twice daily on Face for 28 days. Once at site on forearm Control Intervention1: None: None

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female subjects in general good health in the age range of 18-45 years. 2.Subjects who are willing to use the face serum (and no other leave on moisturizer/serum) during the study duration (7 days) and not apply any product for next 3 days. 3.Subjects willing to not apply any product on volar forearms and come for evaluation at the said time points 4.Subjects who score greater than 30 for sensitive vs resistant skin questionnaire in Dr. Baumannââ?¬•s questionnaire. 5.Subjects who show no irritation up till 30 minutes for product applied behind ear lobe 6.Subjects willing to give a written informed consent and come for regular follow up 7.Subjects who have not participated in a similar investigation in the past eight weeks

Exclusion criteria

Exclusion criteria: 1.Subjects with a present condition of allergic response to any cosmetic product 2.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines etc.) that might influence the outcome of the study. 3.Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids, or any other anti-acne medication) or any topical facial medication within past 4 weeks. 4.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy). 5.Having mild, moderate or severe acne. 6.Subjects with excessive facial hair or scars, which could interfere 7.Subjects with a present condition of allergic response to any cosmetic product. 8.Subjects having cutaneous hypersensitivity. 9.Subjects participating in any other cosmetic or therapeutic trial. 10.Subjects having changed her cosmetic habits required as per protocol before the start of the study on the studied site.

Design outcomes

Primary

MeasureTime frame
Part 1: To evaluate the skin hydration benefits of test products with 7 days of regular usage To evaluate the maintenance of skin hydration for 72 hours Part 2: To evaluate and compare moisturization benefit at 5 min, 24, 48 and 72 hours post product application in comparison to baseline and untreated control To determine the efficacy of test products in providing deep moisturization benefit after tape stripping at 0, 3, 6, 10, 15 strips in comparison to baseline and untreated controlTimepoint: Part 1 - Baseline, Day 4, Day 8 and Day 10 part 2 - Baseline, Immediate, 24, 48 and 72 hrs

Secondary

MeasureTime frame
To evaluate the impact of skin hydrating serum of other associated skin parameters such as texture, elasticity/firmness, skin glow, barrier property etc To evaluate the product safety and tolerance of the test product/s by dermatological assessment.Timepoint: Part 1 - Baseline, Day 4, Day 8 and Day 10 part 2 - Baseline, Immediate, 24, 48 and 72 hrs

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@mscr.in08041125934

Outcome results

None listed

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