P0090 CLINICAL EVALUATION OF CUTANEOUS SAFETY AND EFFICACY OF A FACE EMULSION CONTAINING MYRTACIN EXTRACT, PP VITAMIN ANS SABAL EXTRACT ON ACNE PRONE SKIN SUBJECTS TREATED BY TOPICAL ANTI ACNE DRUG THERAPY. T. NOCERA, V. DUROSIER Pierre-Fabre Dermo-Cosmétique, Toulouse, France
The primary objective of the study was to investigate the clinical safety of a face cream containing myrthacin extract, PP vitamin and sabal extract on subjects presenting acne prone skin treated by topical anti-acne drugs (erythromycin, acid vitamin A and derivative, benzoyl peroxide or associations) after 14 and 28 days of twice-daily use. The secondary objective was to evaluate the cosmetic properties and its efficacy after 28 days. 2
87 volunteers were enrolled to apply the tested cream twice daily, only on affected test area. Inclusion criteria : - Subject presenting a slight to moderate acne. - Subject under topical treatment installed for at least one month and in progress during the study (vitamin A topic or adapalen alone or associated with PBO (4 5 or 10%), erythromycin, azelaïc acid). - Subject under oral acne therapy stopped for at least more than one month for antibiotics and three months for isotretinoïn. A global clinical safety score was determined on objective and subjective safety sign. Subjective efficacy was assed by investigator and patient questionnaire. 3
85 volunteers were analyzed (mean age 21). Table of medical treatments used by the subjects included in the study. Acneic Treatment Number of subjects Adapalen 13 Tretinoin 3 Adapalen + Benzoyl peroxide 14 Azelaïc acid 1 Erythromycin 21 Benzoyl peroxide 33 The tested product was well-tolerated in association with anti acne topical treatments, induced a significant improvement on objective signs observed by investigator and on subjective signs reported by the subjects (p<0.05). 4
After 14 and 28 days of twice-daily use of tested emulsion, a significant improvement in the global objective score (sum of parameters erythema, dryness, edema, desquamation, roughness) was observed by the dermatologist in charge of the study: respectively, on average, -47% on D14 and -64% on D28 (p<0.0001). This effect was observed in 71% of the subjects on D14 and in 86% of the subjects on D28. 5
We observed a significant improvement in : erythema scores on D14 and D28, respectively of -37% (p=0.0003) and -56% (p<0.0001) on average. This effect was observed in 21% of the subjects on D14 and in 33% of the subjects on D28. dryness scores on D14 and D28, respectively of -48% and -72% (p<0.0001) on average. This effect was observed respectively in 44% (D14) and in 61% of the subjects (D28). desquamation scores on D14 and D28, respectively of -61% (p=0.0013) and -57% (p=0.0040) on average. This effect was observed respectively in 19% (D14) and in 21% of the subjects (D28). - roughness scores on D14 and D28, respectively of -46% and -65% (p<0.0001) on average. This effect was observed in respectively 48% (D14) and in 63% of the subjects (D28). 6
After 14 and 28 days of twice-daily use of emulsion a significant improvement in the global subjective score and in tightness scores on D14 and D28, respectively of -75% (p=0.0012) and -79% (p=0.0020) on average. This effect was observed in 15% of the subjects on D14 and in 20% of the subjects on D28. At the end of the study, the great majority of subjects were very satisfied of cosmetic properties and skin efficacy. 87% of them were willing to continue this treatment. 7
Twice-daily use of the tested product during 28 days showed a significant improvement (p<0.0001) in the global objective and subjective (p<0,005) safety scores observed by the dermatologist investigator and 85 acne prone skin subjects treated by topical anti acne drug therapy. 8