Actinic CheilitisPhase 4NCT02409732
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
A Phase 4 study testing aminolevulinic acid hydrochloride and Photodynamic therapy with blue light in people with Actinic Cheilitis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Cheilitis
- What is being tested?
- aminolevulinic acid hydrochloride and Photodynamic therapy with blue light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be able to understand and voluntarily sign an informed consent form
- Must be male or female ≥ 18 years of age at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation
Who cannot join
- Inability to provide voluntarily consent or mentally incompetent
- Active herpes labialis lesions
- Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study
- Subjects with any other skin condition that might affect the evaluation of the study disease
- Pregnant or breastfeeding female subjects
- Subjects who have used any investigational medication within one month prior to study entry
Show all 14Show fewer
- Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis
- Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry
- Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry
- Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity
- Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards, construction workers, frequent sunbed users, etc.)
- Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
- Subjects with a known hypersensitivity to Levulan
- Subjects who are immunocompromised
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.
Read the detailed description
The study will consist of a screening visit, up to three scheduled treatments, and two scheduled office visits. There can be a three-day window period for each scheduled visit in order to accommodate the subject's schedule and unforeseen scheduling conflicts.
- Visit 1 (Screening): Subjects can be screened for the study up to two weeks before Visit 2 (Baseline). During screening, the study will be reviewed, written informed consent obtained, and eligibility confirmed. If applicable, the washout from prohibited medications or treatments will be determined at this visit.
- Visit 2 (Baseline): Following signed, written informed consent and confirmation of eligibility, all subjects will have their lips photographed. Medical history, dermatologic exam, urine pregnancy test (if applicable), review of concomitant medications, clinical evaluations, and tolerability assessments will be performed at this visit. Study medication application to clean skin will be followed by a 90 minute incubation period under occlusion. Subsequently, patients will be exposed to blue light therapy for 16 minutes and 40 seconds. Post-therapy assessments will be performed afterwards, as well as education on appropriate sun protection methods.
- Visits 3-4: Subjects will return every six weeks for up to two additional treatments. Treatment will be discontinued once the patient has achieved clinical clearance. Tolerability assessments, study medication application, blue light therapy, post-therapy assessments, and photographs will be performed.
- Visit 5-6 (End of Study): Subjects will return 12 and 24 weeks after the last treatment for clinical evaluations, tolerability assessments, and photographs.
- Conditions
- Actinic Cheilitis
- Being tested
- aminolevulinic acid hydrochloride, Photodynamic therapy with blue light
- Keywords
- Actinic cheilitis, Photodynamic therapy, Levulan, Blue light
- Medical subject headings
- Actinic cheilitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid hydrochlorideDrug
Also called Levulan, aminolevulinic acid HCl
Photodynamic therapy with blue lightProcedure or surgery
Also called PDT with blue light, PDT
| Study group | Role | What they receive |
|---|---|---|
| PDT | Experimental | PDT with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks for up to three treatments Receives: Drug: aminolevulinic acid hydrochloride; Procedure: Photodynamic therapy with blue light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in Clearance From Baseline
Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.
Measured: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)
Secondary outcomes (4)
Average Change in Participant Reported Pain
Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.
Measured: Baseline to Week 36
Average Change in Local Skin Reactions to Blue Light Treatment
Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.
Measured: Baseline to Week 36
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.
Measured: Baseline to Week 36
Number of Participants With Adverse Events
Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic CheilitisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Michael S. Chapman, Dartmouth-Hitchcock Medical Center
- Investigators
- Michael S Chapman, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409732
- Sponsor's protocol ID
- D15043 28525
- Status last verified
- Oct 2018
- First submitted
- 27 Mar 2015
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ribeiro CF, Souza FH, Jordao JM, Haendchen LC, Mesquita L, Schmitt JV, Faucz LL. Photodynamic therapy in actinic cheilitis: clinical and anatomopathological evaluation of 19 patients. An Bras Dermatol. 2012 May-Jun;87(3):418-23. doi: 10.1590/s0365-05962012000300011.
PubMed 22714758Zaiac M, Clement A. Treatment of actinic cheilitis by photodynamic therapy with 5-aminolevulinic acid and blue light activation. J Drugs Dermatol. 2011 Nov;10(11):1240-5.
PubMed 22052302
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
- ClinicalTrials.gov ID
- NCT02409732
- Acronym / sponsor ID
- D15043 28525
- Conditions
- Actinic Cheilitis
- Keywords
- Actinic cheilitis, Photodynamic therapy, Levulan, Blue light
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- Apr 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.
Detailed description
The study will consist of a screening visit, up to three scheduled treatments, and two scheduled office visits. There can be a three-day window period for each scheduled visit in order to accommodate the subject's schedule and unforeseen scheduling conflicts.
- Visit 1 (Screening): Subjects can be screened for the study up to two weeks before Visit 2 (Baseline). During screening, the study will be reviewed, written informed consent obtained, and eligibility confirmed. If applicable, the washout from prohibited medications or treatments will be determined at this visit.
- Visit 2 (Baseline): Following signed, written informed consent and confirmation of eligibility, all subjects will have their lips photographed. Medical history, dermatologic exam, urine pregnancy test (if applicable), review of concomitant medications, clinical evaluations, and tolerability assessments will be performed at this visit. Study medication application to clean skin will be followed by a 90 minute incubation period under occlusion. Subsequently, patients will be exposed to blue light therapy for 16 minutes and 40 seconds. Post-therapy assessments will be performed afterwards, as well as education on appropriate sun protection methods.
- Visits 3-4: Subjects will return every six weeks for up to two additional treatments. Treatment will be discontinued once the patient has achieved clinical clearance. Tolerability assessments, study medication application, blue light therapy, post-therapy assessments, and photographs will be performed.
- Visit 5-6 (End of Study): Subjects will return 12 and 24 weeks after the last treatment for clinical evaluations, tolerability assessments, and photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDT | Experimental | Drug: aminolevulinic acid hydrochloride, Procedure: Photodynamic therapy with blue lightPDT with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks for up to three treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be able to understand and voluntarily sign an informed consent form
- Must be male or female ≥ 18 years of age at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation
Key exclusion criteria (14 listed)
- Inability to provide voluntarily consent or mentally incompetent
- Active herpes labialis lesions
- Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study
- Subjects with any other skin condition that might affect the evaluation of the study disease
- Pregnant or breastfeeding female subjects
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 hydrochlorideAlso: Levulan, aminolevulinic acid HCl | Drug | PDT |
| Photodynamic therapy with blue lightAlso: PDT with blue light, PDT | Procedure or surgery | PDT |
Primary outcome
Number of Participants With a Change in Clearance From Baseline
Time frame: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)
Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.
4 secondary outcomes
Average Change in Participant Reported Pain
Time frame: Baseline to Week 36
Average Change in Local Skin Reactions to Blue Light Treatment
Time frame: Baseline to Week 36
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Time frame: Baseline to Week 36
Number of Participants With Adverse Events
Time frame: Baseline to Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22714758Ribeiro CF, Souza FH, Jordao JM, Haendchen LC, Mesquita L, Schmitt JV, Faucz LL. Photodynamic therapy in actinic cheilitis: clinical and anatomopathological evaluation of 19 patients. An Bras Dermatol. 2012 May-Jun;87(3):418-23. doi: 10.1590/s0365-05962012000300011.
- Background: PubMed 22052302Zaiac M, Clement A. Treatment of actinic cheilitis by photodynamic therapy with 5-aminolevulinic acid and blue light activation. J Drugs Dermatol. 2011 Nov;10(11):1240-5.
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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.
Michael S Chapman, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 hydrochloride and Photodynamic therapy with blue light in people with Actinic Cheilitis, run by Dartmouth-Hitchcock Medical Center 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 4 inclusion and 14 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 23 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Change in Clearance From Baseline (time frame: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409732, which also lists 2 linked publications.
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 23 Oct 2018.