Summary of clinical results

AVENE
Concentré rougeur

Tolerance and efficacy in monotherapy of ROSAMED Chronic redness concentrate

Tolerance and efficacy in monotherapy of ROSAMED Chronic redness concentrate in adults with mild to moderate erythematotelangiectatic rosacea, under dermatological and ophthalmological control.

Population

44 subjects aged 33 to 65 with erythematotelangiectatic rosacea:

  • Mild to moderate erythema (localized or diffuse)

  • Mild to moderate telangiectasia

100% of subjects with sensitive skin

Application of ROSAMED Chronic redness concentrate

2 applications per day on face, neck and décolleté for 4 weeks

Assessment criteria

  • Auto-assessment of flush severity (GFSS = Global Flushing Severity Score) and flush frequency (score from 0 to 10)
  • Auto-assessment of subjective signs associated with erythematotelangiectatic rosacea (tingling sensations, burning, heat, discomfort)
  • Skin and eye tolerance

Results

  • Highly significant reduction in intensity of flushes from D15: - 30.6% (p<0.001, versus D1)
Image 1

Evolution of flush intensity (GFSS score) over 4 weeks

** p= statistically Highly Significant (p<0,001, versus D1)

 

  • Highly significant decrease in frequency of flushing by D15: - 18.05% (p<0.001, versus D1)
Image 2

Evolution of flush frequency over 4 weeks

** p= statistically Highly Significant (p<0,001, versus D1)

 

Significant improvement in subjective signs associated with erythematotelangiectatic rosacea at 1 month:

  • -71% intensity of tingling sensations (p<0.001, versus D1)
  • -58,7% intensity of pulling sensations (p<0.001, versus J1)
  • -56.8% intensity of burning sensations (p<0.05, versus D1)
  • -17,7% intensity of discomfort sensations (p<0.001, versus D1)

Good skin tolerance and excellent ocular tolerance

Conclusion

ROSAMED Chronic redness concentrate applied twice daily :

  • has demonstrated efficacy on the intensity and frequency of flushing as early as 2 weeks
  • reduces associated signs of discomfort

Good cutaneous tolerance and excellent ocular tolerance