To evaluate the lightning cream in healthy human subjects compared to placebo

Efficacy evaluation of Skin Lightning Creams On Healthy Human Volunteers - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011852

Enrollment

105

Registered

2018-02-12

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: Skin lightening cream: Frequency: Morning And Evening Dose: 1 finger tip unit per application Duration of Application: 5 weeks for each subject Control Intervention1: Placebo: Frequency

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects willing to give a written informed consent and come for regular follow up 2.Subjects in general good health, in the age group of 20 - 45 years 3.Subjects having Chromameter L value less than 55 on cheeks and at least 3 units higher L value on upper volar arm (sun protected site) in comparison to cheeks. 4.At least 5 subjects under each treatment group having acne prone skin 5.At least 5 subjects under each treatment group having few (at least 5) hyper-pigmentation spots on face like solar lentigines and or post acne dark spots other than melasma etc 6.Subjects willing to abstain from using other cosmetic medicinal ayurvedic natural products on face during the study course

Exclusion criteria

Exclusion criteria: 1.Female subjects who are contemplating pregnancy during the study course, or are pregnant as determined by Urine pregnancy test. 2.Subjects who are nursing as revealed by the subjects. 3.Subjects with a known history or present condition of Allergic response to any cosmetic product 4.Subject having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings 5.Subjects having Melasma/ Nevi and other forms of severe photo damage at the site of evaluation (Except Hyperpigmentary age spots/ small post acne marks) 6.Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results 7.Subjects who are involved in heavy physical labor work 8.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation. 9.Subjects with known sensitivity to sun, sunscreens/ cosmetics/ fragrances 10.Subjects having participated in a similar investigation in the past four weeks 11.Subjects who show sensitivity to test formulations in the skin sensitivity test performed on Visit 1 & 2 as a part of screening evaluation.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety & efficacy of investigational products (IP) in lightening the skin in comparison to the baseline and a placebo. Timepoint: 5 Weeks for each subject	—

Secondary

Measure	Time frame
To evaluate the overall changes in skin condition upon usage of IP in comparison to baseline and a placebo.Timepoint: 5 Weeks for each subject	—

Countries

India

Contacts

Public ContactDr Sapna R

MS Clinical Research Pvt Ltd

sapna.r@mscr.in918040917253

Outcome results