Acne VulgarisNCT04631250
Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris
A study testing 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form in people with Acne Vulgaris, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Split-Face Clinical Trial of 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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form
- Keywords
- acne vulgaris, photodynamic therapy, PDT, Daylight PDT
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic Acid-Containing Product in Cutaneous Dose FormDrug
5-Aminolevulinic Acid was applied to both sides of the face.
| Study group | Role | What they receive |
|---|---|---|
| Right: daylight illumination | Experimental | The right side of the face was treated using daylight PDT Receives: 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. Receives: Drug: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: After each of the 4 treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631250
- Sponsor's protocol ID
- 0043-18
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Face Clinical Trial of Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04631250
- Acronym / sponsor ID
- 0043-18
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, photodynamic therapy, PDT, Daylight PDT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Right: daylight illumination | Experimental | Drug: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose FormThe right side of the face was treated using daylight PDT |
| Left face: conventional illumination with red light | Experimental | Drug: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose FormThe left side was treated with conventional PDT. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form5-Aminolevulinic Acid was applied to both sides of the face. | Drug | Left face: conventional illumination with red light, Right: daylight illumination |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Related trials for Acne Vulgaris
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form in people with Acne Vulgaris, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.