Skin Lightening benefits study

Not Applicable

• Registration Number: CTRI/2023/04/051261
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Volunteer in the age group of 19 to 50 years

2· Volunteers with visible skin Tan on face, at least 2 shade darker than a Sun protected upper volar arm

3· Volunteers with a L value in the range of 40 to 60 on cheeks, and L value at least 3 units higher than cheeks on volar upper arm/ bicep area (C1).

4· Participants with varied skin type i.e. normal, dry, oily, combination and sensitive skin in nearly equal ratio

5· At least 15 volunteers with few solar lentigines on face

6· At least 35 volunteers with Persistent Tan (atleast 4weeks old)

7· At least 35 volunteers with a recent tan (Developed on the day of baseline visit)

8· Persistent Tan since (at least 4weeks) and recent tan (Developed on the day of baseline visit) in each case

9· Volunteers willing to abide by the study protocol and refrain from using any product other than the provided Investigational product during the study course.

10· Volunteers willing to visit the site for periodic assessments on the scheduled dates.

11· Volunteer who exhibits good tolerance to the investigational product with no signs of sensitivity in the acute irritation test

Exclusion Criteria

1. Pregnant or lactating women

2· Participants undergoing treatment for Seborrhoea, Acne, Dermatitis, skin lightening/ any other cosmetic/ dermatologic skin condition on face

3· Participants with pre-existing systemic disease requiring long-term medication (self-declaration)

4· Participants with genetic and endocrinal disorders [ self-disclosure]

5· Participants with drug induced acne [ self-disclosure]

6· Participants with any other signs of significant local irritation or skin disease.

7· Participants on oral hormonal treatment or oral medications (e.g., steroids, anti-oxidant) for eight weeks prior to the study which will compromise the study.

8· Participants who may change personal nutrition habits and other habits as per investigatorâ??s discretion.

9· Participants who have participated in a similar investigation or any other clinical product evaluation test in the past four weeks

10· Participants under the influence of alcohol and/or drugs as well as addiction.

11· Participants with severe psychological illness or intellectual inability to understand the study.

12· Participants who have wounds, sunburn, scars, tattoos or piercings at the skin test sites.

13· Participants with uncontrolled disease (severe heart/circulatory, liver, kidney or lung disease, severe diabetes mellitus) or chronic infections (hepatitis, HIV)

14· Participants who have proven allergies against cosmetic ingredients or prior intolerance responses after applying cosmetic products. [self-disclosure]

15· Participants who are taking antihistamines and/or medication to suppress the immune system (e.g., corticoids, cytostatics) and/or retinoids

16· Participants who might participate in any other clinical study during participation in the current study

17· Participants currently taking any medication, which the investigator believes may influence the interpretation of the data.

18· Participants having chronic or acute skin disease at the skin test sites within the last 14 days prior to the beginning of the study and/or during the study or had major surgery in the last year.

19· Participants undergoing any treatment of any active skin condition

20· Participants allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.

21· Participants who are pregnant or nursing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in skin tan and related hyperpigmentation compared to baseline as per Dermatologistâ??s and / or Participantsâ?? self-assessment. <br/ ><br>2· Improvement in skin Lightening, Brightness over baseline by Instrumental measurement and/ or Dermatologistâ??s and / or Participantsâ?? self-assessment.Timepoint: 4 weeks of product use

Secondary Outcome Measures

Name	Time	Method
1. Improvement in below mentioned skin parameters compared to baseline as per Dermatologistâ??s assessment, Participantsâ?? self-assessment and Instrumental measurements <br/ ><br>· Color <br/ ><br>· Hydration/ Moisturization (Instant and Deeper) <br/ ><br>· Texture <br/ ><br>· Epidermal turnover rate / Desquamation <br/ ><br>· Radiance <br/ ><br>· Even tone <br/ ><br>· Clarity <br/ ><br>· Softness / Suppleness <br/ ><br>· Smoothness <br/ ><br>2. Product safety and suitability for varied skin types including sensitive skinTimepoint: 4 weeks of product use