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to access the efficacy of investigational product for it’s salon like tight & bright skin everyday on healthy human female subjects.

Phase 3
Recruiting
Conditions
face brightening & tightening study
Registration Number
CTRI/2013/02/003369
Lead Sponsor
Hindustan Unilever Limited
Brief Summary

Peopleexperience change in skin conditions constantly, due to environmental factors,biological factors, psychological state, lifestyle, grooming and other habitsetc. Some of these changes are perceived fast and some over a period of time.Maintaining a good appearance not withstanding these changes is a justifiableconsumer “wantâ€. In order to fulfill this want and deliver cosmeticallyappealing appearance to skin, people largely resort to cosmetic treatments.

Onecosmetic intervention that is gaining popularity amongst women is a cosmeticproduct that would render their skin tight & bright. Cosmetic scientists,world over are constantly searching for solutions to meet the increasingconsumer preferences.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • 1.Volunteer in generally good health.
  • 2.Volunteer between the ages of 25 and 35 years.
  • 3.Volunteer has done salon visits two times in the last one year for cleanup and facial.
  • 4.Volunteer with Fitzpatrick III or IV skin type.
  • 5.Volunteer having visible significant open pores on face.
  • 6.Volunteer has not participated in a similar clinical investigation in the past four weeks 7.Volunteer with no known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.
  • 8.Volunteer not under any dermatologic treatment / prescribed medications.
  • 9.Volunteer willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.
  • 10.Volunteer willing to visit the site at specified frequencies for periodic evaluations.
  • 11.Volunteer willing to comply with study specific requirements.
Exclusion Criteria
  • 1.A known history or present condition of allergic response to any cosmetic products.
  • 2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
  • 3.On medications (e.g. steroids or antihistamines), which would compromise the study.
  • 4.Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
  • 5.Volunteer; pregnant or nursing.
  • 6.Volunteer viewed by the investigator as not being able to complete the study or participating in another study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objective of the study is to access efficacy of investigational product for it’s salon like tight & bright skin everyday on healthy human female subjects.All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face.
Secondary Outcome Measures
NameTimeMethod
The Secondary objective of this study is to access efficacy of investigational product for the Salon like lightening, Softness, Smoothness, Glow, Younger looking skin etc on the healthy human female subjects.All the subjects will be dermatologically and self assessed at pre product application (T0) and 15 minutes (T1) and 1 hour (T3) post application of investigational product. Instrumental evaluation will be carried out at pre product application (T0) and 1 hour (T2) & 2 hours (T4) post application of investigational product. As per randomization, either of the products will be allotted to all the subjects. Subjects will be asked to apply allotted investigational product on whole face.

Trial Locations

Locations (1)

The KETs Scientific research centre, Cosmetology division

🇮🇳

(Suburban), MAHARASHTRA, India

The KETs Scientific research centre, Cosmetology division
🇮🇳(Suburban), MAHARASHTRA, India
Ms Aditi Barve
Principal investigator
aditi@kelkarcosmetology.com

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