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The efficacy and safety of painless ALA-PDT combined with pretreatment for moderate to severe acne vulgaris.

The efficacy and safety of ALA-PDT combined with pretreatment for moderate to severe acne vulgaris.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046508
Enrollment
Unknown
Registered
2021-05-18
Start date
2019-10-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Acne vulgaris

Interventions

N-PDT group:ALA-PDT without pretreatment
P-PDT group:pretreatment combined with painless ALA-PDT

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 35 years, without cognitive impairment; 2. Diagnosed with acne vulgaris, which accorded with Pillsbury grading III-IV; 3. After fully explaining the purpose and content of this clinical trial (including subjects' compliance, etc.), voluntarily signed an informed consent form to participate in the clinical trial on the basis of full understanding.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to experimental drugs or related drugs; 2. Those who have received acne treatment (ALA-PDT, antibiotics, fruit acid, etc.) within 3 months before entering the group; 3. Those who take phototoxic or photosensitive drugs within 8 weeks before entering the group (such as tetracycline antibiotics, sulfonamides, phenothiazines, etc.); 4. Patients with facial diseases that may affect the evaluation of curative effect (skin photosensitivity, porphyria, other photodermatosis, etc.); 5. Participate in any drug clinical trial within 1 month before this trial (as subjects); 6. Complicated with serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, etc.; 7. Patients with abnormal liver function, dyslipidemia or severe low immunity; 8. Scar physique; 9. Pregnant or lactating women, and subjects of childbearing age (including men) who refused to take appropriate contraceptive measures during the study; 10. Subjects with severe physical or mental illness that researchers believe may affect treatment, evaluation, or poor compliance with the study program.

Design outcomes

Primary

MeasureTime frame
reduction rate of lesions;

Secondary

MeasureTime frame
Pain score;Scores of therapeutic reactions;Incidence of other side effects;

Countries

China

Contacts

Public ContactWang Xiuli

Shanghai Skin Disease Hospital

wangxiuli_1400023@tongji.edu.cn+86 18017336663

Outcome results

None listed

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