CTRI/2012/02/002420
Completed
N/A
Clinical evaluation of the in vivo efficacy of a day cream product at reducing various forms of hyper pigmentation on Asian skin over 3 months in conjunction with a basic night cream, applied under normal conditions of use by adult subjects. - Not Applicable
Oriflame Research and Development Ltd0 sites36 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oriflame Research and Development Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Indian subjects,
- •Sex: female,
- •Age: 18 â?? 65 years old,
- •Subject having at least one of the following on both the left and right profiles of the face
- •\- moderate melasma
- •\- a dark spot severity score of 1\-3 according to the Spot Contrast scale (Skin Ageing Atlas, Asian type by Bazin and Doublet)
- •\- moderate Post Acne hyperpigmentation
- •Fitzpatrick skin types III â?? V,
- •Subject not using skin lightening facial product at least 12 weeks prior to trial,
- •Subject having given freely and expressly her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected,
Exclusion Criteria
- •Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements,
- •Subject who is pregnant or nursing or who is planning a pregnancy during the study,
- •Subject exhibiting active acne,
- •Subject who is acne prone,
- •Subject having started, changed or interrupted any hormonal treatment (contraceptive, HRT, thyroid) during the past 3 months or intending to change during the study,
- •Subject having taken within 12 weeks prior to the study any systemic antibiotics, steroids, or any oral anti acne medications such as retinoids within 6 months prior to the study,
- •Current use of immunosuppressive drugs and/or an organ transplant,
- •Current use of topical or systemic anti\-inflammatory drugs for a defined medical condition, e.g. aspirin, ibuprofen, corticosteroids,
- •Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study,
- •Insulin\-dependent diabetes,
Outcomes
Primary Outcomes
Not specified
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