Abstract
AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE DERMAL SAFETY AND POST-APPLICATION EFFECT OF AN OIL CONTROL MOISTURIZER

Shaheen Majeed, Priti Vaidyanathan, Nirmala Mariyappa, Keerthy Jayalekshmi, Rajalakshmi Ramakrishnaiah*

ABSTRACT

An open label clinical study was carried out to screen the efficacy and safety of an oil control moisturizer containing Policosanol, Aloe vera extract and Niacinamide as its active ingredients. The volunteers of either sex were asked to apply the oil control moisturizer on the face in a circular motion, on cheeks, forehead & Ala of nose once a day for a period of 2 weeks. These volunteers were examined prior to entry into the study and later at seven days interval. Adverse effects, if any, due to application of the oil control moisturizer were noted down. Efficacy of the oil control moisturizer was assessed on the basis of changes in the oiliness and moisturizing effect. Results indicated that the oil control moisturizer was efficacious and was well tolerated. It did not lead to any adverse effects. Aim: To evaluate the safety and efficacy of Oil Control Moisturiser in subjects with excess facial oiliness. Methods: An open label, Phase III clinical trial, evaluating 17 subjects consisted of 3 sessions: baseline, Day 7 and Day 14 for follow up assessments with application of Oil control moisturiser once daily for a period of 2 weeks. Subjects were asked to fill out Oily Skin Self-Assessment Scale (OSSAS) and Oily Skin Impact Scale (OSIS) survey at the first, second and third sessions. At each visit, the cosmetic appearance of the facial skin was scored and usage of oil pads to wipe out oiliness was recorded for efficacy evaluation. Results: The Oil Control Moisturiser showed significant difference in every efficacy parameter at different time points from baseline to end of study as measured by number of oil pads used. From this study, it was evident that application of oil control moisturizer has no serious adverse effects. When applied over a period of 2 weeks, it showed beneficial effects in the form of reduction in shine on skin, improved skin softness, smoothness and moisturizing effect. Overall results were satisfying to the study subjects. Subjects felt that applying oil control moisturizer was beneficial. No subjects experienced any adverse events. Conclusions: Fourteen subjects completed the study. Significant control in the oiliness of skin was seen at the end of the study. Application of this oil control moisturizer is beneficial for oily skin to control excess oiliness of the skin. Product compliance was also good.

Keywords: Oil Control Moisturiser, Oily Skin Self-Assessment Scale, Oily Skin Impact Scale, Sebum, Oiliness.


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