To evaluate the efficacy and in use skin safety of 2 test products [cream containing Sodium Fusidate IP equivalent to Fusidic acid 0.25% w/w in the morning and cream containing Nicotinamide IP 4% w/w in the night] on subjects with moderate facial acne.

Apex Laboratories Pvt Ltd0 sites42 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 12, 2014

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•a)Voluntary males/females with moderate inflammatory acne lesions on entire face.
•b)Above age of 15 years.
•c)No treatment for acne in the past 1 month
•d)All skin types (greasy, normal) except sensitive skin.
•e)Accepting not to use products with the same end benefit during the entire study duration.
•f)Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
•g)Having signed a Consent Form/Parent Consent and Child Assent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

•a)Pregnant women (as confirmed by UPT) and lactating women.
•b)History suggestive of any hormonal problems.
•c)History of allergic dermatitis or contact allergy to cosmetics,
•d)Subjects on oral retinoid since the past 3 months.
•e)Hypersensitivity to any cosmetic product, raw material.
•f)For whom the Investigator considers that he/she will not be compliant with study procedures.
•g)Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
•h)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
•i)Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial