Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study

NCT04709289 | Completed

• 1 other identifier: 2020-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• The clearance rate of lesions

  The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome

  1 week after treatment

Secondary Outcomes (1)

• Assessment of adverse effects

  up to 7 days after treatment.

Study Arms (1)

Conventional Photodynamic Therapy(C-PDT) group

EXPERIMENTAL

The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.

Other: Aminolevulinic acid, photodynamic therapy

Interventions

Aminolevulinic acid, photodynamic therapy OTHER

Aminolevulinic acid, photodynamic therapy

Conventional Photodynamic Therapy(C-PDT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai Dermatology Hospital: lead

Study Sites (1)

Lei Shi

Shanghai, Shanghai Municipality, 200443, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Aminolevulinic Acid; Photochemotherapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Xiuli Wang, MD PhD

  Shanghai Skin Disease Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Evaluator assesses photographs without prior knowledge of intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2020
• Study Completion: February 28, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)