Summary of clinical results

AVENE
Spray asséchant réparateur

Tolerance and efficacy in monotherapy of CICALFATE+ absorbing repair spray

Tolerance and efficacy of CICALFATE+ spray asséchant réparateur as monotherapy in infants, children, adolescents and adults with superficial skin irritations subject to maceration on the face or body, under dermatological and pediatric control.

Population

52 subjects aged 8 months to 53 years with superficial skin irritations subject to maceration on the face or body:

  • Small oozing sores (n=19)
  • Oozing lesions (n=11)
  • Eczema (n=11)
  • Intertrigo of the small and large folds (n=8)
  • Oozing diaper rash (n=3)

Application of CICALFATE+ absorbing repair spray

  • 2 applications per day on irritated areas (face or body) for 3 weeks

Evaluation criteria

  • Clinical scoring of reparative and drying efficacy (Score from 0=ineffective to 3=very effective)
  • Auto-evaluation of discomfort sensations (score from 0 to 10)
  • Skin and gynecological tolerance

Results

  • Drying effectiveness demonstrated after 48h: product effective to very effective for 90% of subjects
image 1

Evolution of drying efficacy (effective to very effective) over 3 weeks

 

  • Significant restorative efficacy demonstrated after 48h: clinical score +75% (p<0.001, versus Timm)
Image 2

Evolution of reparative efficacy over 3 weeks

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

 

  • Sensations of discomfort significantly soothed from the first application: -20% (p<0.001, versus T0)
  • Good skin tolerance

Conclusion

CICALFATE+ absorbing repair spray applied twice daily to superficial skin irritations prone to maceration:

  • has demonstrated drying and repairing efficacy as early as 48h
  • alleviates sensations of discomfort from the first application

Good skin tolerance