Acne
Conditions
Keywords
Acne, low-dose isotretinoin, Photodynamic Therapy, Painless
Brief summary
This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.
Interventions
Aminolevulinic acid photodynamic therapy
DRUGOral conventional-dose isotretinoin
Conventional-dose isotretinoin
DRUGOral low-dose isotretinoin
low-dose isotretinoin
Sponsors
Huadong Hospital
RenJi Hospital
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosed with moderate to severe acne * Male and female patients of age between 18-40 years old * All patients read the instructions of the subject, willing to follow the program requirements * No other topical treatment received within 2 weeks prior to enrollment * No systemic treatment was given within 4 weeks prior to enrollment * Patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion
Exclusion criteria
* Those who did not complete the informed consent * The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound * Patients with skin photoallergic diseases, porphyria * Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs * Patients with other obvious diseases that may affect the evaluation of efficacy * Scars or patients with a tendency to form scars * Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants * Severe heart, liver, kidney disease; with hereditary or acquired coagulopathy * Those with severe neurological, psychiatric or endocrine diseases * Women who are pregnant, breast-feeding or using inappropriate contraceptives -Those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clearance rate of Moderate or Severe Acne | The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment | The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment | The pain will be assessed using Visual Analogue Scale (NRS) with a score range of 0-10. The higher the score, the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment (including immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment. |
Countries
China
Contacts
Primary ContactLei Shi, MD PhD
Backup ContactLinglin Zhang, MD
Outcome results
None listed