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Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

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ClinicalTrials.gov Identifier: NCT04806594
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Relife S.r.l.

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.

Condition or disease Intervention/treatment Phase
Acne Scars Device: Papix acne scar Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Papix acne scar
Papix acne scar gel for 8 consecutive weeks, 2 times per day
Device: 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




Primary Outcome Measures :
  1. To evaluate and confirm the performance of PAPIX ACNE SCAR in the prevention and improvement of scars in subject suffering for mild to moderate acne, after 4 weeks of treatment [ Time Frame: four weeks of treatment ]
    Indicate the proportion of subjects with improved acne scars and marks respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment with the change in the qualitative Scar Global Assessment (SGA) questionnaire.


Secondary Outcome Measures :
  1. To evaluate the performance of PAPIX ACNE SCAR in the prevention and improvement of scars after 2 and 8 weeks of treatment. [ Time Frame: two weeks of treatment and 8 weeks of 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

  2. To evaluate the performance of PAPIX ACNE SCAR in the prevention of lesions after 2, 4 and 8 weeks of treatment [ Time Frame: two weeks, 4 weeks and 8 weeks of treatment ]
    Indicate the prevention of acne lesions after 2, 4 and 8 weeks of treatment.

  3. evaluate acne severity [ Time Frame: two weeks, 4 weeks and 8 weeks of treatment ]
    To evaluate acne severity after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment.

  4. skin roughness improvement [ Time Frame: two weeks, 4 weeks and 8 weeks of treatment ]
    To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment

  5. skin texture improvement [ Time Frame: two weeks, 4 weeks and 8 weeks of treatment ]
    To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment

  6. treatment compliance [ Time Frame: 8 weeks ]
    To evaluate the subject's adherence to treatment by the product accountability.

  7. Subject and Investigator Global Evaluation of Performance [ Time Frame: 8 weeks of treatment ]
    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.

  8. Treatment acceptability [ Time Frame: 8 weeks of treatment ]
    To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.


Other Outcome Measures:
  1. adverse event collection [ Time Frame: two weeks, 4 weeks and 8 weeks of treatment ]
    To evaluate the local and general tolerability of PAPIX ACNE SCAR.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806594


Contacts
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Contact: Aurora Parodi, MD 0105552783 aurora.parodi@hsanmartino.it

Locations
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Italy
Ospedale San Martino Recruiting
Genova, Italy, 16132
Contact: Aurora Parodi, MD    0105555750    aurora.parodi@hsanmartino.it   
Sponsors and Collaborators
Relife S.r.l.
Investigators
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Principal Investigator: Aurora Parodi Ospedale Policlinico San Martino, Genova
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Responsible Party: Relife S.r.l.
ClinicalTrials.gov Identifier: NCT04806594    
Other Study ID Numbers: ReGl/19/PAS-Acn/001
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Relife S.r.l.:
cream
mild moderate acne
Papix
Papix acne scar
acne treatment
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases