Summary of clinical results

Evaluation of the tolerance and efficacy of CICALFATE+ protective repairing cream
Population
253 subjects aged 3 months to 70 years with skin irritations:
- intimate irritations (n=48)
- diaper rash (n=32)
- postpeeling (n=16)
- Irritations post-laser KTP (n=17)
- Irritations postcryotherapy (n=22)
- Various irritations (n=118)
Application of CICALFATE+ protective repairing cream
2 applications per day on irritated areas (face, body, external intimate areas) for 3 weeks
Evaluation criteria
- Clinical scoring of reparative efficacy (Score from 0=ineffective to 3=very effective)
- Self-assessment of discomfort sensations (score from 0 to 10)
- Cutaneous and gynecological tolerance
- Evaluation under dermatological control, pediatric and gynecological control
Results
- Repair effectiveness demonstrated from D3: product effective to very effective for 73% of subjects

Evolution of restorative efficacy (effective to very effective) over 3 weeks
- Sensations of discomfort significantly soothed from the first application: -47% (p<0.001, versus T0)

Evolution of intensity of discomfort sensations over 3 weeks
** p= statistically Highly Significant (p<0,001, versus T0)
- Very good skin tolerance and good gynecological tolerance
Conclusion
CICALFATE+ protective repairing cream applied twice daily:
- demonstrated reparative efficacy as early as 3 days
- alleviates sensations of discomfort from the first application
Very good cutaneous tolerance and good gynecological tolerance
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