None listed
Conditions
Interventions
Intervention1: 1)Neutrogena® ultra sheer SPF 55 + POP base I
2) Neutrogena® healthy skin compact makeup SPF 55 + POP base I
3) Neutrogena® healthy skin compact make up SPF 55 + Night regimen (0.1%
Sponsors
Johnson Johnson Consumer Personal Products World wide
Eligibility
Inclusion criteria
Inclusion criteria: • Female subjects between the ages of 20-40 with Fitzpatrick Skin type III-V. • Subjects must be generally in good health as determined from a recent medical history. • Mild to moderate epidermal and mixed type melasma (score of 1 and 2 on a scale of 0â??3 of melasma severity scale), freckles or post inflammatory hyperpigmentation on both sides of face with sun as the exacerbation factor. • Subjects willing to give the voluntary written informed consent and come for regular follow up. • Subjects willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. • Subject should be willing to abstain from spa treatments/facials during the study period. • Subject must agree to use an active form of birth control other than oral contraceptives. (i.e., condom and/or spermicidal foam, IUD, implant or diaphragm) for the duration of the study. • Is willing to avoid excessive facial sun exposure during the study period. • Subjects who are willing to cleanse the face and remove ALL facial products and all eye makeup at least 30 minutes prior to each study visit. If requested by the staff due to presence of makeup, willingness to wash in the clinic and undergo a 30-minute waiting period prior to having assessments performed. • Subjects who are willing not to start new personal care products (cleansers/cosmetics,etc.) during the study period. • Subjects who are willing not to participate in any other clinical trial during participation in the current trial. • Subject has not participated in a similar investigation in the past four weeks.
Exclusion criteria
Exclusion criteria: • Pregnant (as determined by UPT) or nursing female (as determined by interview). • Has a history of unusual skin reactions to skin care toiletry products, cosmetics, or sensitivity to any of the test product components. • Subjects having facial dermal melasma, lichen planus pigmentosus, slate grey dermal pigmentation or ashy dermatosis. • Subjects with Concurrent therapy, diseases (including eye disease), or skin disorders on facial skin such as allergic contact dermatitis, atopic dermatitis, tinea faciei, tinea barbae, nodulocystic acne, acne conglobata, rosacea and Discoid Lupus Erythematosus/Systemic Lupus Erythematosus which might interfere with evaluation of the test products or increase risk to the subject. • Subjects who have pre-existing or dormant facial dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, seborrheic dermatitis, severe acne/acne conglobata, etc.) that could interfere with the outcome of the study as determined by the investigator. • Subjects with excessive facial hair or scars, which could interfere with expert grader and/or instrumental evaluations. • Subjects who have used topical or oral retinoids and hydroquinone in the past 3 months • Subjects who have undergone facial cosmetic procedures including chemical peels, microdermabrasion, or laser treatment within 6 months. • Subjects with many outdoor activities, who spend or plan to spend large amounts of time in the sun. • Subjects currently using home remedies/ traditional medicine and subjects who are not willing to abstain from the same during study period. • Chronic illness which may influence the cutaneous state. • Subject in an exclusion period or participating in any other cosmetic or therapeutic trial. • Any underlying uncontrolled medical illness including diabetes and hypertension, liver disease or history of alcoholism, hepatitis, or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To investigate the effects of Neutrogena ® sunscreens with and without pigments that absorbs visible light in reduction of facial hyper pigmentation in comparison to baseline. â?¢To investigate the efficacy of Neutrogena ® sunscreen with pigments that absorb visible light in combination with night regimen in reduction of facial hyper pigmentation in comparison to baseline. Timepoint: 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the safety of investigational products by dermatological assessment â?¢ To evaluate the safety and efficacy by subjects self assessment. Timepoint: 7 months. | — |
Countries
India
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt. Ltd
Outcome results
None listed