Acne, Scars
Conditions
Keywords
cream, mild moderate acne, Papix, Papix acne scar, acne treatment
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPapix 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
Sponsors
Relife S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures; 2. Male or female subjects aged ≥ 12 years of any race; 3. Subjects with any Fitzpatrick skin phototype; 4. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face; 5. Presence of acne scars (all types included), of grade mild or moderate according to SGA; 6. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.
Exclusion criteria
1. Pregnant women 2. Severe acne at inclusion or any acne requiring systemic treatment; 3. Presence of facial warts or fungal infections; 4. Active dermatitis on the face, rosacea, active herpes simplex; 5. Keloids presence in the area to be treated or keloids development during the treatment period; 6. History of radiation or skin tumors in the/close to the area to be treated in the past 5 years; 7. Laser ablative procedures within the last month; 8. Chemical peels within the last 6 months; 9. Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks; 10. Use of topical retinoids within 4 weeks; 11. Use of systemic corticosteroids or antibiotics in the previous 30 days; 12. Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months; 13. Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months; 14. Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start; 15. Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations; 16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients; 17. Concomitant or previous participation in other interventional clinical study in the past 3 months; 18. Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks | four weeks of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment | two weeks of treatment and 8 weeks of treatment, week 8 reported | 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 |
| Acne Investigator Global Assessment (IGA) Scores | assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4) | 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; |
| Change of Skin Roughness | assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4) | 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) |
| Number of Partecipants Compliant to Treatment | 8 weeks | To evaluate the subject's adherence to treatment by the product accountability. |
| Subject and Investigator Global Evaluation of Performance | 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. |
| Treatment Acceptability | 8 weeks of treatment ( visit 4) | To evaluate the subject's overall acceptability of the treatment through a specific questionnaire. |
| Number of Partecipants With Skin Texture Improvement | assested at two weeks, 4 weeks and 8 weeks, week 8 reported | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Partecipants With Adverse Events | two weeks, 4 weeks and 8 weeks of treatment | To evaluate the local and general tolerability of PAPIX ACNE SCAR. |
Countries
Italy
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks. 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 | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did never apply the study product and did not attend following visits. | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks. |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Italy | 39 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 9 Participants |
| Subjects had clinical diagnosis of mild to moderate acne vulgaris on the face | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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
Population: 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.).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks | 5 participants |
Secondary
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)
Population: Due to protocol deviation some subjects were not included in all outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Acne Investigator Global Assessment (IGA) Scores | Change of IGA from baseline to Visit 2 (2 weeks) | -0.86 score on a scale | Standard Deviation 0.28 |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Acne Investigator Global Assessment (IGA) Scores | Change of IGA from baseline to Visit 3 (4 weeks) | -0.26 score on a scale | Standard Deviation 0.51 |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Acne Investigator Global Assessment (IGA) Scores | Change of IGA from baseline to Visit 4 (8 weeks) | -0.86 score on a scale | Standard Deviation 0.67 |
Secondary
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)
Population: Due to protocol deviation some subjects were not included in all outcome
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Change of Skin Roughness | Change of skin roughness assessment from baseline to Visit 2 (2 weeks) | -0.38 score on a scale | Standard Deviation 0.35 |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Change of Skin Roughness | Change of skin roughness assessment from baseline to Visit 3 (4 weeks) | -0.11 score on a scale | Standard Deviation 0.4 |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Change of Skin Roughness | Change of skin roughness assessment from baseline to Visit 4 ( 8 weeks) | -0.38 score on a scale | Standard Deviation 0.64 |
Secondary
Number of Partecipants Compliant to Treatment
To evaluate the subject's adherence to treatment by the product accountability.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants Compliant to Treatment | 37 Participants |
Secondary
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
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.).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment | 22 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment | 33 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants With Skin Texture Improvement | 16 Participants |
Secondary
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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Investigator's global evaluation of performance | Worse | 2 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Subject's global evaluation of performance | Very much improved | 7 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Subject's global evaluation of performance | Improved | 13 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Subject's global evaluation of performance | Minimally improved | 11 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Subject's global evaluation of performance | No change | 4 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Subject's global evaluation of performance | Worse | 2 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Investigator's global evaluation of performance | Very much improved | 1 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Investigator's global evaluation of performance | Improved | 19 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Investigator's global evaluation of performance | Minimally improved | 8 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Subject and Investigator Global Evaluation of Performance | Investigator's global evaluation of performance | No change | 7 Participants |
Secondary
Treatment Acceptability
To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Time frame: 8 weeks of treatment ( visit 4)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Treatment Acceptability | Very much satisfied | 7 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Treatment Acceptability | Satisfied | 19 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Treatment Acceptability | Neither satisfied nor dissatisfied | 8 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Treatment Acceptability | Dissatisfied | 2 Participants |
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Treatment Acceptability | Very much dissatisfied | 1 Participants |
Other Pre-specified
Number of Partecipants With Adverse Events
To evaluate the local and general tolerability of PAPIX ACNE SCAR.
Time frame: two weeks, 4 weeks and 8 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype | Number of Partecipants With Adverse Events | 1 Participants |