Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Ligh… (NCT07089368) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris
10 participantsStarted 2026-08
Plain-language summary
This pilot clinical study will evaluate the safety, tolerability, and effectiveness of a novel photodynamic therapy (PDT) for moderate-to-severe acne vulgaris. PDT combines a topical photosensitizing gel with red light to treat acne lesions. The gel to be used in this study, called RLP068/Cl (a zinc phthalocyanine compound), has demonstrated antimicrobial, anti-inflammatory, and sebosuppressive effects in laboratory studies.
A total of 10 patients with moderate-to-severe acne on the face will be enrolled. RLP068/Cl 0.3% gel will be applied topically for 30 minutes under occlusion, followed by 8 minutes of red LED light exposure. Treatments will be performed twice weekly, with the total number of sessions individualized based on clinical response.
Acne severity will be assessed using the Global Acne Grading System (GAGS). Pain levels will be recorded after each session using a visual scale, and patient satisfaction will be evaluated at the end of the treatment cycle.
The goal of the study is to determine whether RLP068/Cl-PDT is a safe, well-tolerated, and effective non-antibiotic treatment option for patients with moderate-to-severe acne vulgaris who may not respond to or tolerate conventional therapies.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Global Acne Grading System (GAGS) score from baseline
Timeframe: End of treatment, expected within 4 to 6 weeks from baseline