NCT06311890

Brief Summary

This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
4mo left

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Feb 2024Sep 2026

First Submitted

Initial submission to the registry

January 14, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

January 14, 2024

Last Update Submit

March 13, 2024

Conditions

AcnePhotodynamic Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Global Acne Grading System (GAGS) Relative to Baseline

    The Global Acne Grading System (GAGS) uses the grading score multiplied by the weight of the position, and the cumulative score is 1-18 for mild, 19-30 for moderate, 31-38 for severe, and above 39 for extremely severe.

    Baseline and 2 weeks/1 month/2 month/6 month after final treatment

Other Outcomes (5)

  • Change in Inflammatory&non-inflammatory Lesion Counts Relative to Baseline

    Baseline and 2 weeks/1 month/2 month/6 month after final treatment

  • Change in Acne-specific Quality of Life Assessment Instrument（Qol-Acne）Relative to Baseline

    Baseline and 2 weeks/1 month/2 month/6 month after final treatment

  • Change in Numerical Rating Scale(NRS) Relative to Baseline

    5 minutes after the start of red light exposure and Immediately after the treatment

  • +2 more other outcomes

Study Arms (2)

photosensitizer group

EXPERIMENTAL

Subjects will receive a photodynamic therapy with chlorin-e6 after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals.

Drug: N-chlorin e6 triglumineProcedure: acne removal surgery

photosensitizer-placebo group

PLACEBO COMPARATOR

Subjects will receive a red light exposure treatment with chlorin-e6 placebo after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals.

Procedure: acne removal surgery

Interventions

N-chlorin e6 triglumineDRUG

a photodynamic therapy with chlorin-e6

Also known as: a red light irradiation
photosensitizer group
acne removal surgeryPROCEDURE

acne removal surgery will be given before red light exposure

photosensitizer groupphotosensitizer-placebo group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is male or non-pregnant female 18 years of age and younger than 50 years of age.
  • Subject has moderate to severe facial acne vulgaris.
  • Subject has provided written informed consent.

You may not qualify if:

  • People who are taking photosensitive drugs;
  • Allergic to any component of the photosensitizer;
  • porphyrins or allergies to porphyrins, with a history of photosensitivity;
  • Pregnant or lactating women and those planning to become pregnant within 3 months;
  • Oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl and other drugs within the past 1 month;
  • Have a history of exposure to sunlight in the past 1 month, have received photoelectric treatment in the past 3 months, or have received facial grinding treatment in the past six months;
  • are using vasodilators (such as nitroglycerin, etc.), beta blockers (such as metoprolol, etc.), anticoagulants (such as warfarin, etc.) and other drugs that easily cause facial capillary dilatation;
  • Patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases;
  • Abnormal blood and urine routine, liver and kidney function, diseases of important organs and hematopoietic system that researchers believe are not suitable for clinical trials;
  • Patients participating in other clinical trials at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization

Beijing, 100091, China

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Huiyan Chi, doctor

    Deputy director of dermatology

    STUDY DIRECTOR

Central Study Contacts

Huiyan Chi, doctor

CONTACT

13811626953chihuiyan@163.com

Yisheng Zhang, doctor

CONTACT

15652386117llleera@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2024

First Posted

March 15, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2024.1-2026.9
More information

Locations

CN(1)