CTRI/2011/04/001672
Completed
Phase 4
Assessment of Efficacy, Safety and Tolerability of Fixed Dose Combination Wunder Eye Cream (3% Biophytex LS 8740 an 5% Proteasyl TP LS 8657) in the treatment of under Eye Dark Circles. - NI
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Glenmark Pharmaceuticals Limited
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?Subjects with mild, moderate or severe under eye dark circles
- •?Subjects must be 18\-50 years of age
- •?Both males and females
- •?Subjects with no history of glaucoma, any eye infection and with normal range of intraocular pressure
- •?Subjects must provide written informed consent and comply to the protocol
- •?Wash out period of 14 or more days prior to enrollment in case of subjects using any other skin care products.
Exclusion Criteria
- •?Subjects not willing to discontinue all topical treatments for ?Under Eye? dark circles for 2 weeks prior to enrollment in study
- •?Hypersensitivity to any ingredients of Wunder Eye cream
- •?Pregnant and lactating women
- •?Subjects taking Concomitant therapy that might interfere with the study results
- •?Subjects with dermatological disorder of face that may interfere with study evaluation
- •?Subjects who have undergone any surgical treatment of the face
- •?Subjects with abnormal intraocular pressure, history of glaucoma and any eye infection on ophthalmological examination
- •?Concomitant topical therapy in under eye area that causes hypopigmentation includes Retinoids and Hydroquinone skin peels.
- •?Concomitant medicines, that cause hyper pigmentation, include Phenothiazines, Anti\-malarials (Chloroquine), Phenytoin sodium, cytotoxic drugs, Sulphonamides.
Outcomes
Primary Outcomes
Not specified
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