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

NCT ID: NCT04631250

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Keywords

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acne vulgaris photodynamic therapy PDT Daylight PDT

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

"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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Right: daylight illumination

The right side of the face was treated using daylight PDT

Group Type EXPERIMENTAL

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Intervention Type DRUG

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

Left face: conventional illumination with red light

The left side was treated with conventional PDT.

Group Type EXPERIMENTAL

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Intervention Type DRUG

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

Interventions

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5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0043-18

Identifier Type: -

Identifier Source: org_study_id