A single blinded, randomized, prospective, single centric, four arms, parallel comparative study to understand the efficacy of Neutrogena sunscreens and Neutrogena sunscreen in combination with night regimen on facial hyperpigmentation

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2012
INTERVENTION: 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% retinol + 1.0% HR (4‐Hexyl Resorcinol) + 2% Soy) : Therapy duration:168 days. Control Intervention1: Untreated Control: POP base II + POP base I: Therapy duration:168 days. CONDITION: Female volunteers with Epidermal/mixed type melasma and other type of hyper pigmentation. PRIMARY OUTCOME: 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 OUTCOME: 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. INCLUSION CRITERIA: â?¢ Female subjects between the ages of 20‐40 with Fitzpatrick Skin type III‐V. â?¢ Subjects must be generally in good health as determined from a recent medical history. â?¢ 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. â?¢ Subjects willing to give the voluntary written informed consent and come for regular follow up. â?¢ Subjects willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. â?¢ Subject should be willing to abstain from spa treatments/facials during the study period. â?¢ 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 t
Epistemonikos ID: b51b80d90f3f0a0b9a4bacbd9abf4ce15b18e8fd
First added on: Aug 22, 2024