Skin pores benefits study

Completed

• Conditions: Healthy male and female participants

• Registration Number: CTRI/2023/04/051262
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Part 1:



The study will be conducted for a period of approximately 4 weeks. On visit 1, the subjects will be selected based on the inclusion and exclusion criteria and will be enrolled after obtaining informed consent. On visit 2, baseline assessments (T0) will be evaluated through visual assessments by Dermatologists, Instrumental evaluations and subjects’ self-assessment.



The subject will be provided with the test product to apply on full face after face wash under the supervision of the study coordinator. Then 1h assessments (1hr after product application) will be performed.



Post completion of the assessment, the subject will be dispensed with the test product and subject diary to carry home and instructed to use for 4- weeks after washing of the face with provided cleanser.



The subjects will be instructed to visit the study centre at day 1, 3, Week 1, 2, 3 & 4 for the follow up assessments.



Part 2:



On visit 2, Two test sites will be identified on the subject’s forearm. The test site identification will be followed by baseline corneometer measurement. Then the test products will be applied on each of the identified sites on the forearm as per randomization. Post 15 min (+15min) of test product application & 72 hrs corneometer measurements will be performed. 20 layers of tape stripping will be performed post product application on the identified test sites and Corneometer measurements will be performed on 0 (before tape stripping), at the end of 5th strip, 10th strip, 15th strip  and 20th tape strip.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-04
• Last Update Posted: 2024-09-09
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

• 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 investigator’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
2· Reduction in the area, density, volume of facial skin pores as per objective assessment	4 weeks of product use
4· Reduction in comedones (Blackheads, Whiteheads)	4 weeks of product use
1. Reduction in the visibility of skin pores as per Dermatologist’s and / or Participants’ assessment	4 weeks of product use
3· Reduction in sebum as per instrumental measurements and Participants’ assessment	4 weeks of product use

Secondary Outcome Measures

Name	Time	Method
Improvement in below mentioned skin parameters as per Dermatologist’s assessment, Participants assessment and Instrumental measurements	· Texture

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt. Ltd.

🇮🇳Bangalore, KARNATAKA, India

Dr Mukesh Ramnane

Principal investigator

08041125934

mukesh.ramnane@msclinical.com