Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne

Acne Clinical Trial

Official title:

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne#a Randomized, Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961607
• Other study ID #: 2019-10
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2019
• Source: Shanghai Dermatology Hospital
• Contact: Yunfeng Zhang, MD
• Phone: +86-18017336550
• Email: yunfeng0519116[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA- PDT) to a conventional regimen for treatment of Moderate or Severe Acne. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosed with moderate to severe acne;

2. Male and female patients of age between 18-30 years old ;

3. All patients read the instructions of the subject, willing to follow the program requirements;

4. No other topical treatment received within 2 weeks prior to enrollment;

5. No systemic treatment was given within 4 weeks prior to enrollment;

6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion. -

Exclusion Criteria:

1. Those who did not complete the informed consent;

2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;

3. Patients with skin photoallergic diseases, porphyria;

4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;

5. Patients with other obvious diseases that may affect the evaluation of efficacy;

6. Scars or patients with a tendency to form scars;

7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;

8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy;

9. Those with severe neurological, psychiatric or endocrine diseases; (10)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.

Related Conditions & MeSH terms

• Acne

Intervention

Procedure:
• Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy

Locations

Country	Name	City	State
China	Yunfeng Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clearance rate of Moderate or Severe Acne	The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment	The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Secondary	Pain assessment	The pain will be assessed using Visual Analogue Scale#VAS) 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 min, 3rd min, 5th min, 7th min, 10th min and 2nd h, 12th h, 24th h and 48th h after treatment.	Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2 hours, 12 hours, 24hours and 48 hours after treatment