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

NCT04631250 | Completed DMC

• 1 other identifier: 0043-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; photodynamic therapy; PDT; Daylight PDT

Outcome Measures

Primary Outcomes (2)

• 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

  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

• Difference in adverse effects between the two sides

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

  After each of the 4 treatment sessions

Study Arms (2)

Right: daylight illumination

EXPERIMENTAL

The right side of the face was treated using daylight PDT

Drug: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Left face: conventional illumination with red light

EXPERIMENTAL

The left side was treated with conventional PDT.

Drug: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form

Interventions

5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form DRUG

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

Left face: conventional illumination with red light; Right: daylight illumination

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Aminolevulinic Acid

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The photographs of the patients were evaluated by two dermatologists blinded to the study protocol.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: "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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: November 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

IL (1)