AcnePhase 2NCT01245946
Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris
A Phase 2 study testing Photodynamic therapy and Conventional therapy in people with Acne, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood. Topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Acne
- What is being tested?
- Photodynamic therapy and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChile
- Study dates
- Oct 2010to May 2011
- Phase
- Phase 2
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 30 years of age with moderate inflammatory acne
Who cannot join
- Those who have received any treatment for acne either topic in the last 3 months before and systemic (including ACO started) in the last 6 months of the study.
- Patients who are pregnant or breastfeeding.
- Patients with history of photosensitivity or autoimmune disease.
- Patients with a history or active TB disease or HIV.
- Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Departamento de dermatología, Centro Médico San Joaquín, Pontificia Universidad Católica de Chile
Santiago, San Joaquín, 1234
About this study
Official title: Efficacy Comparison Study of Topical Aminolaevulinic Acid-Photodynamic Therapy Versus Adapalene Gel 0.1% Plus Doxycycline for Treatment of Moderate Acne Vulgaris. Randomized, Simple Blind, Controlled Trial.
- Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood.
- Topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne.
- Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory acne. Although progress has been made in the study of photodynamic therapy for acne, to date, no study has compared PDT with standard and well-validated pharmaceutical treatments and with the current recommended therapy for most types of acne combination therapy with a topical retinoid plus one or more antimicrobial agents.
Hypothesis
- PDT with the photosensitizer ALA will be effective and safe for the treatment of moderate facial inflammatory acne.
- The ALA-PDT is more effective than conventional therapy with oral antibiotics and topical retinoids in the treatment of moderate inflammatory acne with faster action at 12 weeks of follow-up.
Read the detailed description
- There will be a randomized, controlled, single blind comparison study of PDT with 5-aminolevulinic acid (ALA) 20% versus conventional therapy consisting of topical 0.1% adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory acne.
- Be sought from all patients written informed consent prior to study entry.
- For sample size calculation, we assumed that the correlation is the same in both groups and is relatively low (0.01), the number of lesions per subject is equal in both groups with a mean of 100 and low variance, which take 1 control per case and that. Whereas the percentage of improvement in the control group is 0.6 and expected in the treatment group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new controls.
Interventions:
Patients will be randomized to receive:
- ALA-PDT: In 23 patients applied 20% ALA solution in the affected area for 1.5 hours. Subsequently irradiated with noncoherent red light (lamp Waldmann PDT 1200; wavelength 590-700 nm) with irradiance of 70 mW/cm2 and total dose or fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin nightly topical adapalene 0.1% gel.
- Standard therapy:
In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
- Conditions
- Acne
- Being tested
- Photodynamic therapy, Conventional therapy
- Keywords
- Acne moderate, Photodynamic Therapy, Topical retinoids, Antimicrobial agents
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
Also called PDT
Photodynamic therapy: 2 sessions separated by 2 weeks of TDF with topical ALA20% for 1.5 hrs, then irradiated with red light (Waldmann lamp) at a fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin adapalene 0.1% gel until 12 weeks
Also called Adapalene plus doxycycline
Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy | Experimental | Not described Receives: Procedure: Photodynamic therapy |
| Conventional therapy | Experimental | Not described Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion counts
Be conducted by an investigator blinded to the interventions, count of inflammatory and non-inflammatory acne lesions at the start of treatment and controls at the sixth and twelfth week.
Measured: Twelve weeks
Secondary outcomes (1)
Photographic scores, quality of life, adherence to treatment and global severity of acne
The researchers will make assessment of the quality of life, adherence to treatment, global severity of acne and scars and blemishes record at the beginning and end of the study (12 weeks).
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Hasson, MD, Study chair, Dermatology department, Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245946
- Sponsor's protocol ID
- 10-146
- Status last verified
- Nov 2010
- First submitted
- 22 Nov 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison Study of Topical Aminolaevulinic Acid-Photodynamic Therapy Versus Adapalene Gel 0.1% Plus Doxycycline for Treatment of Moderate Acne Vulgaris. Randomized, Simple Blind, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01245946
- Acronym / sponsor ID
- 10-146
- Conditions
- Acne
- Keywords
- Acne moderate, Photodynamic Therapy, Topical retinoids, Antimicrobial agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Nov 2010 (estimated)
- 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.
- Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood.
- Topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne.
- Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory acne. Although progress has been made in the study of photodynamic therapy for acne, to date, no study has compared PDT with standard and well-validated pharmaceutical treatments and with the current recommended therapy for most types of acne combination therapy with a topical retinoid plus one or more antimicrobial agents.
Hypothesis
- PDT with the photosensitizer ALA will be effective and safe for the treatment of moderate facial inflammatory acne.
- The ALA-PDT is more effective than conventional therapy with oral antibiotics and topical retinoids in the treatment of moderate inflammatory acne with faster action at 12 weeks of follow-up.
Detailed description
- There will be a randomized, controlled, single blind comparison study of PDT with 5-aminolevulinic acid (ALA) 20% versus conventional therapy consisting of topical 0.1% adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory acne.
- Be sought from all patients written informed consent prior to study entry.
- For sample size calculation, we assumed that the correlation is the same in both groups and is relatively low (0.01), the number of lesions per subject is equal in both groups with a mean of 100 and low variance, which take 1 control per case and that. Whereas the percentage of improvement in the control group is 0.6 and expected in the treatment group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new controls.
Interventions:
Patients will be randomized to receive:
- ALA-PDT: In 23 patients applied 20% ALA solution in the affected area for 1.5 hours. Subsequently irradiated with noncoherent red light (lamp Waldmann PDT 1200; wavelength 590-700 nm) with irradiance of 70 mW/cm2 and total dose or fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin nightly topical adapalene 0.1% gel.
- Standard therapy:
In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | Experimental | Procedure: Photodynamic therapy |
| Conventional therapy | Experimental | Drug: Conventional therapy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women between 18 and 30 years of age with moderate inflammatory acne
Key exclusion criteria (5 listed)
- Those who have received any treatment for acne either topic in the last 3 months before and systemic (including ACO started) in the last 6 months of the study.
- Patients who are pregnant or breastfeeding.
- Patients with history of photosensitivity or autoimmune disease.
- Patients with a history or active TB disease or HIV.
- Patient refusal to participate in the study.
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 |
|---|---|---|
| Photodynamic therapyAlso: PDTPhotodynamic therapy: 2 sessions separated by 2 weeks of TDF with topical ALA20% for 1.5 hrs, then irradiated with red light (Waldmann lamp) at a fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin adapalene 0.1% gel until 12 weeks | Procedure or surgery | Photodynamic therapy |
| Conventional therapyAlso: Adapalene plus doxycyclineConventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks. | Drug | Conventional therapy |
Primary outcome
Lesion counts
Time frame: Twelve weeks
Be conducted by an investigator blinded to the interventions, count of inflammatory and non-inflammatory acne lesions at the start of treatment and controls at the sixth and twelfth week.
1 secondary outcome
Photographic scores, quality of life, adherence to treatment and global severity of acne
Time frame: Twelve weeks
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 1 Jun 2011.
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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.
Ariel Hasson, MD study chair
Dermatology department, Pontificia Universidad Católica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photodynamic therapy and Conventional therapy in people with Acne, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 1 inclusion and 5 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 1 Jun 2011. 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 Chile. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lesion counts (time frame: Twelve weeks). 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 1 Jun 2011.