MedPath

To access the efficacy of test product for it’s salon fair look everyday on healthy human female subjects.

Phase 2
Completed
Conditions
Fairness cream study
Registration Number
CTRI/2018/02/011784
Lead Sponsor
Hindustan Unilever Limited
Brief Summary

People experience change in skin conditions constantly, due to environmental factors, biological factors, psychological state, lifestyle, grooming and other habits etc. Some of these changes are perceived fast and some over a period of time. Maintaining a good appearance notwithstanding these changes is a justifiable consumer “wantâ€. In order to fulfill this want and deliver cosmetically appealing appearance to skin, people largely resort to cosmetic treatments.

 One cosmetic intervention that is gaining popularity amongst women is a cosmetic product that would render their skin fair and moisturized. Cosmetic scientists, world over are constantly searching for solutions to meet the increasing consumer preferences and to ascertain associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • 1.Subject in generally good health.
  • 2.Subject between the ages of 18 to 30 years.
  • 3.Subject has done salon visits two times in the last one year for cleanup and facial.
  • 4.Subject with Fitzpatrick III & IV skin type.
  • 5.Subject has not participated in a similar clinical investigation in the past four weeks.
  • 6.Subject with no known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.
  • 7.Subject not under any dermatologic treatment / prescribed medications.
  • 8.Subject willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.
  • 10.Subject willing to comply with study specific requirements.
  • 11.Subject willing to give a written informed consent and come for regular observation.
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.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.Subject 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
to ascertain the salon like fairness everyday and associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjectsBaseline, week 1,week 2& week4
Secondary Outcome Measures
NameTimeMethod
to ascertain the salon like fairness everyday and associated skin attributes like softness, smoothness, overall appearance, glow, de-tanning, evenness etc on the healthy human female subjectsBaseline, week 1,week 2& week4

Trial Locations

Locations (1)

The KET’s, Scientific Research Centre, Cosmetology Division,

🇮🇳

Mumbai, MAHARASHTRA, India

The KET’s, Scientific Research Centre, Cosmetology Division,
🇮🇳Mumbai, MAHARASHTRA, India
Ms Meghana Surve
Principal investigator
02225639644
meghana@kelkarcosmetology.com

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