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Efficacy study and safety evaluation clinical trial of red light photodynamic combined with supramolecular salicylic acid in the treatment of moderate to severe acne

Efficacy study and safety evaluation clinical trial of red light photodynamic combined with supramolecular salicylic acid in the treatment of moderate to severe acne

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079708
Enrollment
Unknown
Registered
2024-01-10
Start date
2024-01-20
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne

Interventions

ALA-PDT:After the patient cleansed the face, the prepared 5% ALA was evenly applied to the subject's face with a thickness of about 1mm, protected from light for 0.5 hours, the residual ALA was wiped
ALA-PDT-ASA:After the patient cleansed the face, the prepared 5% ALA was evenly applied to the subject's face with a thickness of about 1mm, protected from light for 0.5 hours, the residual ALA was wi

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-55 years old, no cognitive dysfunction, male or female; 2) The diagnosis and grading of acne patients refer to the Pillsbury grading method, and the patients with grade II~IV moderate and severe acne located on the face are selected; 3) After giving a full explanation of the purpose and content of this clinical trial (including the matters to be complied with by the subjects, etc.), on the basis of full understanding, voluntarily sign the informed consent form to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1) Those who are known to be allergic to the experimental drug or related drugs and products; 2) Those who have undergone photodynamic therapy within 12 weeks and those who have applied any other treatment that affects the study (3 months before enrollment, 1 month before enrollment, 1 month before enrollment, 2 weeks before enrollment, etc.); 3) Those who have taken phototoxic or photosensitizing drugs (such as sulfonamides, phenothiazines, etc.) within 8 weeks before enrollment; 4) Patients with other facial diseases that may affect the efficacy evaluation (dermatitis, eczema, other photodermatoses, etc.); 5) Those who are known to suffer from skin photoallergy, porphyria or allergy to ALA and photo; 6) Participation in any drug clinical trial (as a subject) within 1 month prior to participating in this trial 7) Combined with serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, etc.; 8) Those with scar constitution; 9) pregnant or lactating women, and subjects of childbearing potential (including males) who refuse to use adequate contraception during the study; 10) Subjects with severe physical or psychiatric illness that, in the opinion of the investigator, may affect treatment, evaluation, or poor compliance with the study protocol.

Design outcomes

Primary

MeasureTime frame
Assessment of skin lesions;

Secondary

MeasureTime frame
Skin barrier testing;

Countries

China

Contacts

Public ContactWang Dixin

Skin Disease Hospital of Tongji University

dd_dream@qq.com+86 136 6188 2914

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026