Skip to content

To study the effect of Under Eye Cream in Healthy Human Volunteers compared to Placebo.

A Phase II randomized, double blind placebo controlled study to evaluate the efficacy and safety of Under Eye Cream in healthy human volunteers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002601
Enrollment
30
Registered
2012-04-25
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: Under Eye Cream: Frequency:Twice daily- morning and night. Dose: lentil size on the distal phalynx of ring finger per application. Mode of application: dab it on from the medial to late

Sponsors

Sami labs
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects in generally good health. Subjects of skin types III, IV, and V. Subjects age group 18 - 55 years Subjects willing to give a written informed consent and come for a regular follow up. Subject willing to abide by and comply with the study protocol. Subject has not participated in a similar investigation in the past four weeks. Subjects having mild to severe infra orbital melanosis and fine lines. Subjects with no history of glaucoma, any eye infection. Subjects who have not taken any under eye treatments for at least 14 days prior to enrolment. Subject should be willing to abstain from spa treatments/facials during the study period. Subject is not pregnant (as determined by interview),and she must agree to use an active form of birth control (i.e, stabilized on oral contraceptives, condom and /or spermicidal foam, IUD, implant, or diaphragm ) for the duration of the study.

Exclusion criteria

Exclusion criteria: Pregnant or nursing female (as determined by interview). A known history or present condition of allergic response to any cosmetic products. Concomitant topical therapy in under eye area that causes hypopigmentation includes Retinoids and Hydroquinone skin peels. Subjects taking concomitant therapy (such as oral anti oxidants, vitamin E) that might interfere with the study results. Subjects with dermatological disorder of face that may interfere with study evaluation. Subjects with history of abnormal intraocular pressure, history of glaucoma and any eye infection during enrolment Concomitant medicines, that cause hyper pigmentation, include Phenothiazines, Anti-malarials (Chloroquine), Phenytoin sodium, cytotoxic drugs, Sulphonamides. Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy. Subjects not willing to discontinue other topical anti ageing, anti wrinkle facial products. Hypersensitivity to any component of the tested products. History of intense sun exposure. Chronic illness which may influence the cutaneous state. Subject participating in any other cosmetic or therapeutic trial. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. Subjects who have undergone filler treatment under the eye within the past three months.

Design outcomes

Primary

MeasureTime frame
1.Lightening of the under eye dark circles in comparison to baseline and placebo. 2.Reduction of fine lines, wrinkles under the eyes in comparison to baseline and placebo. 3.Reduction of puffiness under the eye in comparison to baseline and placebo. Timepoint: 1.Lightening of the under eye dark circles in comparison to baseline and placebo. 2.Reduction of fine lines, wrinkles under the eyes in comparison to baseline and placebo. 3.Reduction of puffiness under the eye in comparison to baseline and placebo.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS CLINICAL RESEARCH PVT. LTD

mukta.sachdev@mscr.in9180-40917253

Outcome results

None listed

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