Acne VulgarisPhase 1NCT01830764
Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
A Phase 1 study testing Red Light (PDT) in people with Acne Vulgaris, run by Dermira, Inc. at 1 site in United States.
Trial summary
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Red Light (PDT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18 years of age or older
- Fitzpatrick skin types I-IV
Who cannot join
- Current pregnancy or lactation.
- Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
- Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
- Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
- Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
- Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
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- Abnormal findings on screening ECG deemed clinically significant by the Investigator.
- Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
- Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
- Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Trial locations and contacts
1 site in 1 country.
United States1 site
TKL Research Inc (Research Clinics Division)
Paramus, New Jersey, 07652
About this study
Official title: An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
Read the detailed description
This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.
- Conditions
- Acne Vulgaris
- Being tested
- Red Light (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.
Red Light (PDT)Drug
Also called LTS-PDT
LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)
| Study group | Role | What they receive |
|---|---|---|
| Red light dose (PDT) 75 J/cm2 | Other | Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2 Receives: Drug: Red Light (PDT) |
| Red Light (PDT) 150 J/cm2 | Other | Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2 Receives: Drug: Red Light (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dosik, MD, Principal investigator, TKL Research Inc (Research Clinics Division)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830764
- Sponsor's protocol ID
- LTS-ACN06
- Status last verified
- Jul 2021
- First submitted
- 10 Apr 2013
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01830764
- Acronym / sponsor ID
- LTS-ACN06
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dermira, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Apr 2013 (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.
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
Detailed description
This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red light dose (PDT) 75 J/cm2 | Other | Drug: Red Light (PDT)Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2 |
| Red Light (PDT) 150 J/cm2 | Other | Drug: Red Light (PDT)Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults 18 years of age or older
- Fitzpatrick skin types I-IV
Key exclusion criteria (10 listed)
- Current pregnancy or lactation.
- Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
- Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
- Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
- Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
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 |
|---|---|---|
| Red Light (PDT)Also: LTS-PDTLTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2) | Drug | Red Light (PDT) 150 J/cm2, Red light dose (PDT) 75 J/cm2 |
Primary outcome
Adverse Events
Time frame: 1 week
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
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 20 Jul 2021.
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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.
Jonathan S Dosik, MD principal investigator
TKL Research Inc (Research Clinics Division)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Red Light (PDT) in people with Acne Vulgaris, run by Dermira, Inc. 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 2 inclusion and 10 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 20 Jul 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events (time frame: 1 week). 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 20 Jul 2021.