Summary of clinical results

Tolerance and efficacy of CICALFATE+ scar gel as monotherapy
Tolerance and efficacy of CICALFATE+ scar gel as monotherapy in adolescents and adults with post-act residual marks, under dermatological and ophthalmological control
Population
54 subjects aged 12 to 64 with post-act residual marks on the face or body:
- Post-sutures (n=10)
- Post-caesarians (n=9)
- Post-surgery / face (n=10)
- Post-surgery / body (n=18)
- Post-surgery / scalp (n=7)
Application of CICALFATE+ scar gel
- 2 applications per day on residual marks (face or body) for 3 months
Evaluation criteria
- Clinical scoring of scar appearance (POSAS score, Patient and Observer Scar Assessment Scale)
- Rating of associated redness (spectrocolorimetry)
- Auto-evaluation of discomfort sensations (score from 0 to 10)
- Skin and eye tolerance
Results
- Highly significant improvement in scar appearance from D22 perceived by investigators: POSAS score -27% (p<0.001, versus T0)

Changes in investigator-rated POSAS score over 3 months
** p= highly significant (p<0,001, versus T0)
- Highly significant reduction in associated redness from first application: -5% (p<0.001, versus T0)

Evolution of associated redness intensity (spectrocolorimetric measurements) over 3 months
** p= highly significant (p<0,001, versus T0)
- Sensations of discomfort significantly alleviated by D22: -38% (p<0.001, versus T0)

Changes in intensity of discomfort sensations over 3 months
** p= highly significant (p<0,001, versus T0)
- Very good skin and ocular tolerance
Conclusion
CICALFATE+ scar gel applied twice daily:
- improves the appearance of scars from 3 weeks
- decreases associated redness from the first application. application
Very good skin and eye tolerance
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