Trial Outcomes & Findings for Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. (NCT NCT04806594)
NCT ID: NCT04806594
Last Updated: 2025-01-08
Results Overview
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.
COMPLETED
NA
40 participants
four weeks of treatment
2025-01-08
Participant Flow
A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).
Participant milestones
| Measure |
PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.
Papix acne scar gel for 8 consecutive weeks, 2 times per day
PAPIX ACNE SCAR was topically applied twice a day for 8 weeks, 2 FTU (finger-tip units) in the morning and in 2 FTU the evening before bedtime, on the face, and massaged gently into the skin until absorbed.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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37
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.
Papix acne scar gel for 8 consecutive weeks, 2 times per day
PAPIX ACNE SCAR was topically applied twice a day for 8 weeks, 2 FTU (finger-tip units) in the morning and in 2 FTU the evening before bedtime, on the face, and massaged gently into the skin until absorbed.
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Did never apply the study product and did not attend following visits.
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1
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Baseline Characteristics
A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).
Baseline characteristics by cohort
| Measure |
PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.
n=39 Participants
Patients will be instructed to use PAPIX ACNE SCAR applied twice a day, in the morning and in the evening before bedtime, and massaged gently into the skin until absorbed. PAPIX ACNE SCAR shall be applied only on the lesions, where possible. The treatment duration will be of 8 weeks
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Age, Categorical
<=18 years
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11 Participants
n=5 Participants • A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).
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Age, Categorical
Between 18 and 65 years
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28 Participants
n=5 Participants • A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants • A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).
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Sex: Female, Male
Female
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30 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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39 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Italy
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39 Participants
n=5 Participants
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Subjects had clinical diagnosis of mild to moderate acne vulgaris on the face
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39 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: four weeks of treatmentPopulation: PPAS population: Per-Protocol analysis set (PPAS): all patients of the FAS who also meet all inclusion/exclusion criteria and who do not have any major protocol deviation (i.e. wrong inclusion, use of forbidden concomitant medications, etc.).
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.
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=39 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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|---|---|
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Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks
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5 participants
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SECONDARY outcome
Timeframe: two weeks of treatment and 8 weeks of treatment, week 8 reportedPopulation: Per-Protocol analysis set (PPAS): all patients of the FAS who also meet all inclusion/exclusion criteria and who do not have any major protocol deviation (i.e. wrong inclusion, use of forbidden concomitant medications, etc.).
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
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
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22 Participants
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SECONDARY outcome
Timeframe: assested at two weeks, 4 weeks and 8 weeks, week 8 reportedProportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
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33 Participants
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SECONDARY outcome
Timeframe: assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)Population: Due to protocol deviation some subjects were not included in all outcome
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;
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=39 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Acne Investigator Global Assessment (IGA) Scores
Change of IGA from baseline to Visit 2 (2 weeks)
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-0.86 score on a scale
Standard Deviation 0.28
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Acne Investigator Global Assessment (IGA) Scores
Change of IGA from baseline to Visit 3 (4 weeks)
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-0.26 score on a scale
Standard Deviation 0.51
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Acne Investigator Global Assessment (IGA) Scores
Change of IGA from baseline to Visit 4 (8 weeks)
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-0.86 score on a scale
Standard Deviation 0.67
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SECONDARY outcome
Timeframe: assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)Population: Due to protocol deviation some subjects were not included in all outcome
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)
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=39 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Change of Skin Roughness
Change of skin roughness assessment from baseline to Visit 2 (2 weeks)
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-0.38 score on a scale
Standard Deviation 0.35
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Change of Skin Roughness
Change of skin roughness assessment from baseline to Visit 3 (4 weeks)
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-0.11 score on a scale
Standard Deviation 0.40
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Change of Skin Roughness
Change of skin roughness assessment from baseline to Visit 4 ( 8 weeks)
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-0.38 score on a scale
Standard Deviation 0.64
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SECONDARY outcome
Timeframe: assested at two weeks, 4 weeks and 8 weeks, week 8 reportedTo evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Number of Partecipants With Skin Texture Improvement
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16 Participants
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SECONDARY outcome
Timeframe: 8 weeksTo evaluate the subject's adherence to treatment by the product accountability.
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Number of Partecipants Compliant to Treatment
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37 Participants
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SECONDARY outcome
Timeframe: 8 weeks of treatment ( visit 4)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.
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Subject and Investigator Global Evaluation of Performance
Subject's global evaluation of performance · Worse
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2 Participants
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Subject and Investigator Global Evaluation of Performance
Investigator's global evaluation of performance · Very much improved
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1 Participants
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Subject and Investigator Global Evaluation of Performance
Investigator's global evaluation of performance · Improved
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19 Participants
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Subject and Investigator Global Evaluation of Performance
Subject's global evaluation of performance · Very much improved
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7 Participants
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Subject and Investigator Global Evaluation of Performance
Subject's global evaluation of performance · Improved
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13 Participants
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Subject and Investigator Global Evaluation of Performance
Subject's global evaluation of performance · Minimally improved
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11 Participants
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Subject and Investigator Global Evaluation of Performance
Subject's global evaluation of performance · No change
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4 Participants
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Subject and Investigator Global Evaluation of Performance
Investigator's global evaluation of performance · Minimally improved
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8 Participants
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Subject and Investigator Global Evaluation of Performance
Investigator's global evaluation of performance · No change
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7 Participants
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Subject and Investigator Global Evaluation of Performance
Investigator's global evaluation of performance · Worse
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2 Participants
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SECONDARY outcome
Timeframe: 8 weeks of treatment ( visit 4)To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=37 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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|---|---|
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Treatment Acceptability
Very much satisfied
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7 Participants
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Treatment Acceptability
Satisfied
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19 Participants
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Treatment Acceptability
Neither satisfied nor dissatisfied
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8 Participants
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Treatment Acceptability
Dissatisfied
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2 Participants
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Treatment Acceptability
Very much dissatisfied
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1 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: two weeks, 4 weeks and 8 weeks of treatmentTo evaluate the local and general tolerability of PAPIX ACNE SCAR.
Outcome measures
| Measure |
No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype
n=39 Participants
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Papix acne scar: 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
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Number of Partecipants With Adverse Events
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1 Participants
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Adverse Events
Safety Population)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Population)
n=40 participants at risk
To evaluate the local and general tolerability of PAPIX ACNE SCAR. Adverse events and adverse reactions were recorded and evaluated.
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General disorders
mild foot contusion).
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2.5%
1/40 • Number of events 1 • All subjects enrolled were treated with PAPIX ACNE SCARS for 8 weeks
Only one adverse event was registered during the study. The event was not related to the study treatment (mild foot contusion).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place