Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris

Launched by UNIVERSITÀ DEGLI STUDI DI BRESCIA · Jul 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for moderate-to-severe acne on the face using a special gel combined with red light therapy. The gel, called RLP068/Cl, contains a compound that has shown promise in fighting bacteria, reducing inflammation, and controlling oil production in the skin. During the treatment, the gel will be applied to the face for 30 minutes, followed by 8 minutes of exposure to red LED light. This process will be done twice a week, with the total number of sessions adjusted based on how well the acne improves. The study aims to see if this treatment is safe, comfortable, and effective, especially for people who haven’t had success with or cannot use standard acne medications.

People who are 16 years or older with moderate-to-severe acne on both sides of their face may be eligible to join. To participate, individuals must not have used oral acne medicines for at least six months or topical acne treatments for at least two months before starting. The study will exclude those who have conditions that make their skin sensitive to light, are pregnant or breastfeeding, or have other skin problems that could affect the results. Participants can expect to have their acne severity checked regularly, be asked about any pain during treatment, and share their satisfaction at the end. This trial offers a potential new option for those looking for non-antibiotic acne treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female participants aged ≥16 years.
• • Diagnosis of moderate-to-severe acne vulgaris (comedonal, papulopustular, or cystic), with facial lesions symmetrically distributed.
• • Washout period of at least 6 months from prior oral acne treatments.
• • Washout period of at least 2 months from prior topical acne treatments.
• • Ability to understand the study procedures and provide written informed consent.
• Exclusion Criteria:
• • Use of systemic or topical photosensitizing medications.
• • Known photosensitivity disorders.
• • Pregnancy or breastfeeding.
• • Participation in another interventional clinical study within the past 3 months.
• • Any dermatological condition of the face that may interfere with treatment assessment (e.g., eczema, rosacea).
• • Any serious uncontrolled medical condition deemed by the investigator to pose a risk to the participant or interfere with study results.