AcnePHOTACNCT07089368
Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris
A study testing Zn(II)-phthalocyanine gel in people with Acne, run by Università degli Studi di Brescia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Zn(II)-phthalocyanine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Zn(II)-phthalocyanine gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zn(II)-phthalocyanine gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RLP068/Cl Photodynamic Therapy | Experimental | Not described Receives: Drug: Zn(II)-phthalocyanine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment, expected within 4 to 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Bighetti, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089368
- Sponsor's protocol ID
- 2025BSDR09C
- Acronym
- PHOTAC
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07089368
- Acronym / sponsor ID
- PHOTAC / 2025BSDR09C
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RLP068/Cl Photodynamic Therapy | Experimental | Drug: Zn(II)-phthalocyanine gel |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zn(II)-phthalocyanine gelTopical 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. | Drug | RLP068/Cl Photodynamic Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Zn(II)-phthalocyanine gel in people with Acne, run by Università degli Studi di Brescia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Bighetti, MD (+39 0303995301, s.bighetti@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Acne Grading System (GAGS) score from baseline (time frame: End of treatment, expected within 4 to 6 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.