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

Not Applicable

Not yet recruiting

• Conditions: Acne
• Interventions: Drug: Zn(II)-phthalocyanine gel

• Registration Number: NCT07089368
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-20
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2025-10
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RLP068/Cl Photodynamic Therapy	Zn(II)-phthalocyanine gel	-

Primary Outcome Measures

Name	Time	Method
Change in Global Acne Grading System (GAGS) score from baseline	End of treatment (EOT), expected within 4 to 6 weeks from baseline	The Global Acne Grading System (GAGS) is a validated tool that assesses acne severity based on lesion type and anatomical location. The outcome will be measured as the change in total GAGS score from baseline to the end of treatment.