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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Aminolevulinic acid, photodynamic therapy

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Lei Shi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional Photodynamic Therapy(C-PDT) group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of adverse effects

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.

Full Information

NCT ID

NCT04709289

First Posted

January 10, 2021

Last Updated

January 13, 2021

Sponsor

Shanghai Dermatology Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04709289

Brief Title

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

Official Title

Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Dermatology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Evaluator assesses photographs without prior knowledge of intervention

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Photodynamic Therapy(C-PDT) group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Aminolevulinic acid, photodynamic therapy

Intervention Description

Aminolevulinic acid, photodynamic therapy

Primary Outcome Measure Information:

Title

The clearance rate of lesions

Description

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

Time Frame

1 week after treatment

Secondary Outcome Measure Information:

Title

Assessment of adverse effects

Description

Time Frame

up to 7 days after treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, MD PhD

Organizational Affiliation

Shanghai Skin Disease Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Lei Shi

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200443

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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