The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks and 3 clinical follow up visits will be performed.
The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks, 2 times per day into the face. The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration
Ospedale San Martino
Genova, Italy
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks
The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.
Time frame: four weeks of treatment
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire
Time frame: two weeks of treatment and 8 weeks of treatment, week 8 reported
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).
Time frame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Acne Investigator Global Assessment (IGA) Scores
To evaluate acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA). Five different grades were used to define the acne severity: 0 Clear, 1 Almost Clear, 2 Mild, 3 Moderate, 4 Severe;
Time frame: assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change of Skin Roughness
To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment Acne Investigator Global Assessment (IGA)
Time frame: assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)
Number of Partecipants With Skin Texture Improvement
To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).
Time frame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Number of Partecipants Compliant to Treatment
To evaluate the subject's adherence to treatment by the product accountability.
Time frame: 8 weeks
Subject and Investigator Global Evaluation of Performance
To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire.
Time frame: 8 weeks of treatment ( visit 4)
Treatment Acceptability
To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Time frame: 8 weeks of treatment ( visit 4)