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NCT Number: NCT04631250

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

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.

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Key information

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Drug

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

Primary outcomes

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

    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

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

  2. Difference in adverse effects between the two sides

    Time frame: After each of the 4 treatment sessions

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

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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