Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 9:50 AM
Study NCT ID:
NCT07089368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Università degli Studi di Brescia
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHOTAC
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: