Actinic KeratosesPhase 4NCT02622594
Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times
A Phase 4 study testing Aminolevulinic Acid (ALA), Environ Cosmetic Roller and BLU-U IIlluminator in people with Actinic Keratoses, run by Dermatology, Laser & Vein Specialists of the Carolinas at 1 site in United States.
Trial summary
This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses. Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment 2, Treatment 3 or Treatment 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Aminolevulinic Acid (ALA), Environ Cosmetic Roller and BLU-U IIlluminator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 13 Apr 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or non-pregnant female over the age of 18 years. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent.
- Subject has four (4) or more AK lesions on each side of the face.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject has Fitzpatrick skin type I-IV
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis or any condition with associated immunosuppression (e.g. HIV, systemic malignancy, etc.).
- Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject has Fitzpatrick skin type V - VI.
- Subject is currently enrolled in an investigational drug or device study.
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- Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
- Subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Subject has used any of the following topical preparations on the area(s) to be treated
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.
- Cryotherapy, dicofenac or other treatments for AK within 8 weeks of initiation of treatment
- Microdermabrasion, laser ablative treatments or chemical peels within 8 weeks of the initiation of treatment.
- 5-FU, imiquimod or ALA-PDT within 6 months of initiation of treatment.
- Subject has used any of the following systemic medications:
- Immuno-suppressants including steroids, chemotherapy, etc. within 3 months of the initiation of treatment
- Retinoid therapy within 6 months of the initiation of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
About this study
Official title: A Randomized, Evaluator-blinded, Bilateral Comparison of the Treatment of Facial Actinic Keratoses Using Combination Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Different Incubation Times
This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.
Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment 2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal dorsum, the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline, the nose and the chin), the upper lip (not including the vermilion border) and the chin (bounded by the lower edge of the vermilion border, the cheek junction and the jawline). The treatment areas will be not be occluded. A line will be drawn with a marker that intersects the nose, forehead, upper lip and chin in the midline. The left face is defined as the face to the left of this line and the right face is defined as the face to the right of this line. Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment and at 1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded with respect to the randomization will conduct grading of the subject's actinic keratoses and photodamage. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.
Safety will be evaluated by adverse events and local skin responses reported during the study
- Conditions
- Actinic Keratoses
- Being tested
- Aminolevulinic Acid (ALA), Environ Cosmetic Roller, BLU-U IIlluminator
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid (ALA)Drug
Also called Levulan Kerastick applicator
Environ Cosmetic RollerDevice
Also called Microneeling
BLU-U IIlluminatorDevice
Also called Blue light
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Receives: Drug: Aminolevulinic Acid (ALA); Device: Environ Cosmetic Roller; Device: BLU-U IIlluminator |
| 2 | Active comparator | Treatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Receives: Drug: Aminolevulinic Acid (ALA); Device: Environ Cosmetic Roller; Device: BLU-U IIlluminator |
| 3 | Active comparator | Treatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Receives: Drug: Aminolevulinic Acid (ALA); Device: Environ Cosmetic Roller; Device: BLU-U IIlluminator |
| 4 | Active comparator | Treatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Receives: Drug: Aminolevulinic Acid (ALA); Device: Environ Cosmetic Roller; Device: BLU-U IIlluminator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy-Percentage of treatment areas with >75% reduction in lesion count as compared to baseline
Measured: 6 months
Efficacy-Percentage of treatment areas with 100% cure rate as compared to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology, Laser & Vein Specialists of the Carolinas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622594
- Sponsor's protocol ID
- ADV Microneedling/PDT 002
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Bilateral Comparison of the Treatment of Facial Actinic Keratoses Using Combination Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Different Incubation Times
- ClinicalTrials.gov ID
- NCT02622594
- Acronym / sponsor ID
- ADV Microneedling/PDT 002
- Conditions
- Actinic Keratoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dermatology, Laser & Vein Specialists of the CarolinasUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 4 Dec 2015 (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.
This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.
Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment 2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal dorsum, the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline, the nose and the chin), the upper lip (not including the vermilion border) and the chin (bounded by the lower edge of the vermilion border, the cheek junction and the jawline). The treatment areas will be not be occluded. A line will be drawn with a marker that intersects the nose, forehead, upper lip and chin in the midline. The left face is defined as the face to the left of this line and the right face is defined as the face to the right of this line. Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment and at 1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded with respect to the randomization will conduct grading of the subject's actinic keratoses and photodamage. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.
Safety will be evaluated by adverse events and local skin responses reported during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Aminolevulinic Acid (ALA), Device: Environ Cosmetic Roller, Device: BLU-U IIlluminatorTreatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). |
| 2 | Active comparator | Drug: Aminolevulinic Acid (ALA), Device: Environ Cosmetic Roller, Device: BLU-U IIlluminatorTreatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). |
| 3 | Active comparator | Drug: Aminolevulinic Acid (ALA), Device: Environ Cosmetic Roller, Device: BLU-U IIlluminatorTreatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). |
| 4 | Active comparator | Drug: Aminolevulinic Acid (ALA), Device: Environ Cosmetic Roller, Device: BLU-U IIlluminatorTreatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male or non-pregnant female over the age of 18 years. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent.
- Subject has four (4) or more AK lesions on each side of the face.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject has Fitzpatrick skin type I-IV
Key exclusion criteria (20 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis or any condition with associated immunosuppression (e.g. HIV, systemic malignancy, etc.).
- Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject has Fitzpatrick skin type V - VI.
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 |
|---|---|---|
| Aminolevulinic Acid (ALA)Also: Levulan Kerastick applicator | Drug | 1, 2, 3, 4 |
| Environ Cosmetic RollerAlso: Microneeling | Device | 1, 2, 3, 4 |
| BLU-U IIlluminatorAlso: Blue light | Device | 1, 2, 3, 4 |
Primary outcome
Efficacy-Percentage of treatment areas with >75% reduction in lesion count as compared to baseline
Time frame: 6 months
Efficacy-Percentage of treatment areas with 100% cure rate as compared to baseline
Time frame: 6 months
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 19 Jul 2017.
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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.
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 Phase 4 study testing Aminolevulinic Acid (ALA), Environ Cosmetic Roller and BLU-U IIlluminator in people with Actinic Keratoses, run by Dermatology, Laser & Vein Specialists of the Carolinas at 1 site in United States.
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 20 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 19 Jul 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy-Percentage of treatment areas with >75% reduction in lesion count as compared to baseline (time frame: 6 months). 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 19 Jul 2017.