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

NCT07089368 | Not Yet Recruiting

• 1 other identifier: 2025BSDR09C
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Change in Global Acne Grading System (GAGS) score from baseline

  The Global Acne Grading System is a validated acne severity assessment tool based on lesion type and anatomical location. In this study, the facial Global Acne Grading System score will be calculated by assessing the forehead, right cheek, left cheek, nose, and chin. The total facial score ranges from 0 to 32, with higher scores indicating more severe acne. The primary outcome will be the change in total facial Global Acne Grading System score from baseline to the end of treatment; a reduction in score indicates clinical improvement.

  End of treatment, expected within 4 to 6 weeks from baseline

Study Arms (1)

RLP068/Cl Photodynamic Therapy

EXPERIMENTAL

Drug: Zn(II)-phthalocyanine gel

Interventions

Zn(II)-phthalocyanine gel DRUG

Topical application of RLP068/Cl 0.3% gel (Zn(II)-phthalocyanine) at a dose of 1 mL per 25 cm² under occlusion for 30 minutes, followed by red light irradiation at 630 nm (60 J/cm²) for 8 minutes. Sessions will be repeated twice weekly until clinical response is achieved.

RLP068/Cl Photodynamic Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Stefano Bighetti, MD

CONTACT

+39 0303995301; s.bighetti@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share