Italian company started a clinical investigation on the Safety and Clinical Performance of Papix Acne Scar

Photo by Megan Bagshaw

The company Relife is conducting the clinical trial Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

The scope of this 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.

It is planned to include 40 participants.

Actual study start date is September 25, 2020. The researchers expect to complete the study by September 30, 2021.

Among the inclusion conditions appear:

  • Male or female subjects aged ≥ 12 years of any race.
  • Participants with any Fitzpatrick skin phototype.
  • Participants 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.
  • Participants 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.

There are a number of conditions that do not allow participation, such as:

  • 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.

The full list can be viewed at the link below.

The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04806594) Genova, Italy.

Clinical Research News

Próximos ensaios clínicos