MedPath

Skin pores benefits study

Not Applicable
Registration Number
CTRI/2023/04/051262
Lead Sponsor
ITC Life Sciences Technology Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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

2· Participants with enlarged skin pores, varied skin types including Sensitive skin

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

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

5· Participants willing to visit the site for periodic assessments on the scheduled dates.

6· Participants who exhibits good tolerance to the investigational product with no signs of sensitivity.

7· Participants who agree to refrain from any other test product during the study

8· Participants willing to give voluntary written informed consent and photography release.

9· Participants willing to abide by and comply with the study protocol.

10· Participants able to read and sign an appropriate informed consent form indicating their willingness to participate.

11· Participants willing and capable to follow the study rules and a fixed schedule.

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
NameTimeMethod
1. Reduction in the visibility of skin pores as per Dermatologistâ??s and / or Participantsâ?? assessment <br/ ><br>2· Reduction in the area, density, volume of facial skin pores as per objective assessment <br/ ><br>3· Reduction in sebum as per instrumental measurements and Participantsâ?? assessment <br/ ><br>4· Reduction in comedones (Blackheads, Whiteheads)Timepoint: 4 weeks of product use
Secondary Outcome Measures
NameTimeMethod
Improvement in below mentioned skin parameters as per Dermatologistâ??s assessment, Participants assessment and Instrumental measurements <br/ ><br>· Texture <br/ ><br>· Epidermal turnover rate / Desquamation <br/ ><br>· Hydration/ Moisturization (Instant, Longevity and Deeper) <br/ ><br>· Firmness / Resilience <br/ ><br>· Radiance <br/ ><br>· Even tone <br/ ><br>· Clarity <br/ ><br>· Softness <br/ ><br>· SmoothnessTimepoint: 4 weeks of product use
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