Skip to content

To study the effect of Anti Ageing and Regeneration Cream in Healthy Human Volunteers compared to placebo.

A Phase II, randomized, double blind, placebo controlled, monocentric study to evaluate the efficacy and safety of Anti Ageing and Regeneration Cream in Healthy Human Volunteers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002771
Enrollment
30
Registered
2012-07-05
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: Anti ageing and regeneration cream. Control-Placebo : Frequency of application- twice a day- morning and night. Dose of application- one finger tip unit per application. Site of applic

Sponsors

Sami Labs
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in generally good health Subjects of skin types III, IV, and V. Subjects age group 30 - 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 visible fine lines and wrinkles in periorbital area (Crowâ??s feet),nasolabial areas, forehead ,and perioral regions of the face Subjects having mild to moderate nasolabial folds Subjects having apparent mild to moderate crowâ??s feet in unanimated face Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months. Subject should be willing to abstain from spa treatments/facials during the study period

Exclusion criteria

Exclusion criteria: A known history or present condition of allergic response to any cosmetic products. Subjects having severe photoaging. Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. 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. Subjects who are pregnant, lactating or nursing. 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.

Design outcomes

Primary

MeasureTime frame
To study product performance in reduction in number and depth of facial wrinkles, fine lines, nasolabial fold and crowâ??s feet in comparison to baseline and placebo.Timepoint: 84 days (12 weeks)from the day of first application of the cream.

Secondary

MeasureTime frame
â?¢ To study product performance in reduction of facial wrinkles in comparison to baseline and placebo. to evaluate the moisturization effect in comparison to baseline and placebo.Timepoint: 12 Weeks.

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