To evaluate the anti-aging efficacy of the products in healthy human volunteers

Efficacy evaluation of cosmetic formulation in conferring anti-skin aging benefits in healthy human volunteers - None

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016533

Enrollment

Registered

2018-12-05

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: Product-PS: One pump of the provided investigational product to be applied on face, twice daily (post morning bath and 2 hours prior to bed time after having washed face with the provid

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject is willing to give a written informed consent 2.Subject is a healthy adult male and female in the age range of 35-60 years 3.Subjects with mild to moderate wrinkle crowÃ¢â?¬•s feet on scale 3 and above, referring to the Modified Anti-Ageing Atlas- 6 point scale. 4.Subject has at least 2 dark spots on face that are age spots/lentigines-marks other than melasma/chloasma. 5.In case of having used fairness products/skin anti-aging products in the near past subject willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face. 6.Subjects willing to abstain from using any cosmetic/ medicinal/ ayurvedic/ natural products other than the one provided for testing on face during the study course. 7.Female subjects of reproductive age group willing to undergo UPT at time of screening visit. 8.Subject who shows good tolerance (no sensitivity symptoms) to the investigational products during the skin sensitivity test

Exclusion criteria

Exclusion criteria: 1.Subjects who are pregnant or lactating or contemplating pregnancy during the study course 2.Subjects with a known history or present condition of allergic response/ sensitivity to sun, sunscreens/ cosmetics/ fragrances 3.Subject having skin condition like psoriasis, atopic dermatitis or other cutaneous manifestations which would interfere with the test readings 4.Subjects on medications like retinoid, steroids, antihistamines, oral contraceptives, or those for hormonal balance which could compromise the study results 5.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation 6.Subjects having participated in a similar investigation in the past 2 month

Design outcomes

Primary

Measure	Time frame
The dermatological safety and anti- aging efficacy of the investigational product (IP) over baselineTimepoint: Approximately 8 weeks	—

Secondary

Measure	Time frame
The safety of the investigational product (IP).Timepoint: Approximately 8 weeks	—

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@mscr.in08041125934

Outcome results