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

Phase 2

Completed

• Registration Number: CTRI/2018/02/011852
• Lead Sponsor: ITC Life Science and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-08-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 95

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified