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Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, photodynamic therapy, PDT, Daylight PDT

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with a clinical diagnosis of acne vulgaris on the face
Acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones.
Acne refractory to conventional therapies
Patients who are unable or do not want to take oral isotretinoin
Patients who cannot tolerate isotretinoin

Exclusion Criteria:

History of oral retinoid use within 12 months of study entry
Systemic antibiotics within 6 month of study entry
Topical acne treatment within 1 month of study entry
Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea
Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics).
Pregnancy or intention to get pregnant
lactating woman
Porphyria
Photosensitive dermatoses
Allergy to any component of the photosensitizer compound
Personal history of melanoma or dysplastic nevi
A beard or other facial hair that might interfere with study assessments;

Sites / Locations

Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Right: daylight illumination

Left face: conventional illumination with red light

Arm Description

The right side of the face was treated using daylight PDT

The left side was treated with conventional PDT.

Outcomes

Primary Outcome Measures

Reduction in acne lesion counts and total acne severity score on both sides of the face

Change in the number of inflammatory and non-inflammatory acne lesions

Difference in adverse effects between the two sides

Difference in pain scores, erythema after each treatment, erosions and pustulosis

Secondary Outcome Measures

Full Information

NCT ID

NCT04631250

First Posted

November 10, 2020

Last Updated

November 10, 2020

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04631250

Brief Title

Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris

Official Title

A Split-Face Clinical Trial of Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

July 1, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris. The study aims to determine whether treatment with daylight as an illumination source is as effective as conventional, red light illumination. 15 patients with acne vulgaris received 4 treatment sessions at three-week intervals. First, 5-aminolevulinic acid (ALA) was applied to the entire face. Then the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

Detailed Description

Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris .One of the most important drawbacks of PDT is the pain during illumination. It has been shown that daylight PDT is an effective treatment for actinic keratosis. In order to examine the efficacy of daylight PDT for acne vulgaris, we used a split-face design: the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to daylight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

6. Conditions and Keywords

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

Acne Vulgaris

Keywords

acne vulgaris, photodynamic therapy, PDT, Daylight PDT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

"Split Face design" is a common model used in dermatology to study the difference between two treatments on a facial condition. The face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

Masking

Outcomes Assessor

Masking Description

The photographs of the patients were evaluated by two dermatologists blinded to the study protocol.

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Right: daylight illumination

Arm Type

Experimental

Arm Description

The right side of the face was treated using daylight PDT

Arm Title

Left face: conventional illumination with red light

Arm Type

Experimental

Arm Description

The left side was treated with conventional PDT.

Intervention Type

Drug

Intervention Name(s)

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Intervention Description

5-Aminolevulinic Acid was applied to both sides of the face.

Primary Outcome Measure Information:

Title

Reduction in acne lesion counts and total acne severity score on both sides of the face

Description

Change in the number of inflammatory and non-inflammatory acne lesions

Time Frame

We measured the difference between the number of lesions in the first visit and the number of lesions in the follow up visit, 12 weeks after the last teatment

Title

Difference in adverse effects between the two sides

Description

Difference in pain scores, erythema after each treatment, erosions and pustulosis

Time Frame

After each of the 4 treatment sessions

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a clinical diagnosis of acne vulgaris on the face Acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones. Acne refractory to conventional therapies Patients who are unable or do not want to take oral isotretinoin Patients who cannot tolerate isotretinoin Exclusion Criteria: History of oral retinoid use within 12 months of study entry Systemic antibiotics within 6 month of study entry Topical acne treatment within 1 month of study entry Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics). Pregnancy or intention to get pregnant lactating woman Porphyria Photosensitive dermatoses Allergy to any component of the photosensitizer compound Personal history of melanoma or dysplastic nevi A beard or other facial hair that might interfere with study assessments;

Facility Information:

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

12. IPD Sharing Statement

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Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris

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