Acne Vulgaris
Conditions
Brief summary
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
Detailed description
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
Interventions
OTHERAminolevulinic acid, photodynamic therapy
Aminolevulinic acid, photodynamic therapy
Sponsors
Shanghai Dermatology Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Evaluator assesses photographs without prior knowledge of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ; * (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives; * (3) Patients who read the instructions and were willing to follow the program requirements.
Exclusion criteria
* (1) Patients who had a history of photosensitive diseases; * (2) Patients who had Modified-PDT; * (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks; * (4) Female patients who were pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clearance rate of lesions | 1 week after treatment | The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse effects | up to 7 days after treatment. | the incidence, severity, occurrence and duration time of erythema, pain, burning skin, itching, pustule, exudation, edema, blister, dry skin, crust and hyperpigmentation of last treatment, as well as lesion photos were detailed asked and recorded during the clinical encounter, up to 7 days after treatment. |
Countries
China
Outcome results
None listed