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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: End of treatment, expected within 4 to 6 weeks 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Bighetti, MD

CONTACT

[email protected]

+39 0303995301

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Acronym: PHOTAC

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jul 28, 2025
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting