Study of effectiveness of a day cream product in combination with a night cream in reducing dark spots in asian adult females over a period of 3 months

Completed

• Conditions: Asian females with melasma, Ageing Spots, Post- acne Inflammatory Hyperpigmentation

• Registration Number: CTRI/2012/02/002420
• Lead Sponsor: Oriflame Research and Development Ltd

Brief Summary

This study intends to evaluate the efficacy of the care product “24883 Day Cream SPF40 Formula No. Alt 18â€, in association with two basic night creams and assess its cosmetic qualities, after application for 84 consecutive days under the normal conditions of use on female Indian adult subjects. The primary objectives is to determine the anti-hyperpigmentation and lightening effect of the care product “24883 Day Cream SPF40 Formula No. Alt 18†when used in combination with Night Cream A compared to when used in combination with Night Cream B, on female Indian adult subjects in three groups of melasma, ageing spots and post acne hyperpigmentation. The secondary objective is to report intolerance sensations.  The product application will be done for consecutive 84 days. The study duration is 3 months. The anti-hyperpigmentation and lightening effects will be evaluated by (1) clinical scoring of the severity of different hyperpigmentations on left and right cheeks by the dermatologist investigator (2) image analysis for the front, left and right profiles of images of subjects face captured using VISA-CR, (3) subjective evaluation of the effects of the products and cosmetic acceptability by the subjects. The study is comparative, open-labeled and randomized, with respect to the night creams. Night creams A and B will be applied on each hemi- face.  0.5 g (pea size amount) of each of the product (day cream in the day and night cream at night) will be applied to the hemi-face. Day cream would be applied to the entire face (0.5 g left and 0.5 g right). Each of the subject will apply both night cream A and B on either side of the face according to the randomization sequence.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-13
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• • Healthy Indian subjects, • Sex: female, • Age: 18 – 65 years old, • Subject having at least one of the following on both the left and right profiles of the face.
• moderate melasma.
• a dark spot severity score of 1-3 according to the Spot Contrast scale (Skin Ageing Atlas, Asian type by Bazin and Doublet).
• moderate Post Acne hyperpigmentation • Fitzpatrick skin types III – V, • Subject not using skin lightening facial product at least 12 weeks prior to trial, • Subject having given freely and expressly her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected, • Subject who is able to read and understand documents transmitted (consent and information sheet), • Subject accepting not to apply cosmetic products other than those she usually applies and at their usual frequency of application, • Subject having access to health services.

Exclusion Criteria

• Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements, • Subject who is pregnant or nursing or who is planning a pregnancy during the study, • Subject exhibiting active acne, •Subject who is acne prone, • Subject having started, changed or interrupted any hormonal treatment (contraceptive, HRT, thyroid) during the past 3 months or intending to change during the study, • Subject having taken within 12 weeks prior to the study any systemic antibiotics, steroids, or any oral anti acne medications such as retinoids within 6 months prior to the study, • Current use of immunosuppressive drugs and/or an organ transplant, • Current use of topical or systemic anti-inflammatory drugs for a defined medical condition, e.g. aspirin, ibuprofen, corticosteroids, • Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study, • Insulin-dependent diabetes, • Immune deficiency or autoimmune disease, • Skin disorders affecting the study area which, in the investigator’s judgment, would interfere with the grading / assessment of the skin response (e.g. acne, psoriasis, scars, hyperhidrosis, etc, …), • Subjects with any skin disorder that could compromise evaluation of skin reactions, • Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study, • Current participation in another clinical study of any kind, • Subject who cannot be contacted in case of emergency, • Febrile disease in the three days preceding the study, • Personnel of the investigating laboratory.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical scoring by the dermatologist investigator on the evolution of the different types of hyperpigmentations, according to defined scales	Day 0, Day 28, Day 56 and Day 84
2. Image analysis of the images captured for the front, left and right profiles of subjects face with VISIA-CR, under standard-2 and cross-polarized light.	Day 0, Day 28, Day 56 and Day 84
3. Subjective evaluation of the anti-hyperpigmentation and lightening effects of the	Day 0, Day 28, Day 56 and Day 84
investigational products and of its cosmetic acceptability by the subjects	Day 0, Day 28, Day 56 and Day 84

Secondary Outcome Measures

Name	Time	Method
Report of intolerance sensations.	Day 0, Day 28, Day 56 and Day 84

Trial Locations

Locations (1)

CIDP Biotech India Pvt. Ltd.; 🇮🇳 South, DELHI, India

CIDP Biotech India Pvt. Ltd.

🇮🇳South, DELHI, India

Dr Sah Gaurang Krishna

Principal investigator

01140793385

gaurangkrishna3@gmail.com