A Split-Face Clinical Trial of Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Reduction in acne lesion counts and total acne severity score on both sides of the face
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The photographs of the patients were evaluated by two dermatologists blinded to the study protocol.
Eligibility Criteria
- Ages
- 14 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Right: daylight illumination
The right side of the face was treated using daylight PDT
Intervention: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form (Drug)
Left face: conventional illumination with red light
The left side was treated with conventional PDT.
Intervention: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported