Summary of clinical results

Tolerance and efficacy in monotherapy of CICALFATE+ hydrating skin repairing emulsion
Tolerance and efficacy of CICALFATE+ repairing moisturizer as a monotherapy treatment on post-act or post-tattoo adults, under dermatological control.
Population
62 subjects aged 18 to 65 with post-act or post-tattoo skin irritations:
- Tattooing (n=19)
- Pulsed light (n=11)
- ND Yag laser. (n=11)
- Peeling (n=9)
- Laser KTP (n=6)
- Microneedling (n=6)
Application of CICALFATE+ hydrating skin repairing emulsion
- 2 applications per day on irritated areas (face or body) for 3 weeks
Evaluation criteria
- Evaluation of clinical and functional signs associated with skin irritation (score from 0=absent to 4=severe)
- Clinical rating of reparative efficacy (Ineffective to very effective)
- Clinical rating of antimarks (Ineffective to very effective)
- Self-assessment of burning sensations (score from 0 to 10)
- Skin tolerance
Results
Statistically significant reduction in all physical and functional signs associated with skin irritation immediately after application (p<0,05, versus T0)
Repairing efficacy rated good to very good by investigators for 90% of subjects from 2 days of application

Investigator rating of reparative efficacy over 3 weeks
Antimark rated good to very good by investigators for 98% of subjects after 2 days of application
- Significantly soothed burning sensations from the first application: -60% (p<0.001, versus T0)
- Very good skin tolerance
Conclusion
CICALFATE+ hydrating skin repairing emulsion applied twice-daily post-act or post-tattoo :
- has demonstrated repairing and anti-marking efficacy as early as 2 days of application
- alleviates burning sensations as early as the first application
Very good skin tolerance
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