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

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    40
  • sponsor
    Relife S.r.l.
Updated on 27 March 2021

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.

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.

Details
Condition Acne Vulgaris, Scar, Acne, Scar Tissue, acnes
Treatment Papix acne scar
Clinical Study IdentifierNCT04806594
SponsorRelife S.r.l.
Last Modified on27 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures
Male or female subjects aged 12 years of any race
Subjects with any Fitzpatrick skin phototype
Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face
Presence of acne scars (all types included), of grade mild or moderate according to SGA
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

Pregnant women
Severe acne at inclusion or any acne requiring systemic treatment
Presence of facial warts or fungal infections
Active dermatitis on the face, rosacea, active herpes simplex
Keloids presence in the area to be treated or keloids development during the treatment period
History of radiation or skin tumors in the/close to the area to be treated in the past 5 years
Laser ablative procedures within the last month
Chemical peels within the last 6 months
Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks
Use of topical retinoids within 4 weeks
Use of systemic corticosteroids or antibiotics in the previous 30 days
Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months
Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months
Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start
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
Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients
Concomitant or previous participation in other interventional clinical study in the past 3 months
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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