Acne VulgarisPhase 4ChromogenixNCT02647528
A Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
A Phase 4 study testing Chromogenix Regenlite Transform Treatment in people with Acne Vulgaris, run by Sadick Research Group at 1 site in United States.
Trial summary
A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Chromogenix Regenlite Transform Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization.
- Healthy male or non-pregnant female 18-65 years-of-age with a clinical diagnosis of mild to moderate facial acne vulgaris.
- Subject must have at least eight and not more than fifty inflammatory facial lesions (i.e., papules/pustules) and no nodules on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area including those present on the nose. Lesions involving the eyes, and scalp should be excluded from the count.
- Subject must be in general good health and free from any clinically significant disease, other than acne, that might interfere with the study evaluations.
- Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up brand/type and frequency of use throughout the study.
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- Subjects must agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study.
- Subjects must understand the study and be able to follow study instructions as well as attend the required study visits.
- Subjects who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
Who cannot join
- Subjects whom are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study.
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of acne.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne.
- The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000units/day (multivitamins are allowed).
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- The use of estrogens or oral contraceptives for less than 3 months prior to baseline.
- The use within 1 month prior to baseline of:
- topical retinoids to the face;
- systemic antibiotics known to have an impact on the severity of facial acne (e.g., containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim);
- systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose).
- Use within 2 weeks prior to baseline of:
- topical corticosteroids;
- topical antibiotics;
- topical medications for acne (e.g., metronidazole).
- Subjects with moderate or severe rhinophyma, dense telangiectases (score 3, severe), or plaque-like facial edema.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
- A subject who has used a sauna during the 2 weeks prior to study entry and during the study.
- Subjects who have performed wax epilation of the face within 14 days prior to baseline.
- A subject with bacterial folliculitis.
- A subject who consumes excessive alcohol, abuses drugs or has a condition that could compromise the subject's ability to comply with study requirements.
- Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- A subject who has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.
- A subject who has used any topical azelaic acid therapy within 30 days of baseline visit.
- Subjects who have participated in an investigational drug study (i.e., subjects have been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
- Subjects who have been previously enrolled in this study.
- Subjects who have had laser therapy (for telangiectasia or other conditions), electrodessication and phototherapy to the facial area within 180 days prior to study entry.
- Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the Investigational Product within 14 days prior to study entry.
- Subjects who have had any kind of facial dermabrasion, chemical peel, laser, IPL or any other treatment that could influence the skin quality in the past 6 months or for the duration of the study
- Subjects who do not agree to avoid using tanning beds or intensive exposure to the sun two weeks prior to each office visit.
- Subjects who have any known cancer including skin cancers (basal cell carcinoma, squamous cell carcinoma and melanoma) in the treatment area.
- Subjects who are currently involved in any injury litigation claims.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Chromogenix Regenlite Transform Treatment, Chromogenix Regenlite Transform Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromogenix Regenlite Transform TreatmentDevice
Pulse Dyed Laser - 7mm spot size 3-3.6 J/cm2
Chromogenix Regenlite Transform PlaceboDevice
Pulse Dyed Laser - 7mm spot size 0 J/cm2
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients in this arm receive treatment Receives: Device: Chromogenix Regenlite Transform Treatment |
| Placebo | Placebo comparator | Patients in this arm do not receive treatment Receives: Device: Chromogenix Regenlite Transform Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Acne Assessment Scoring
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: funding withdrawn
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647528
- Sponsor's protocol ID
- Chromogenex Acne
- Acronym
- Chromogenix
- Status last verified
- Dec 2016
- First submitted
- 31 Dec 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02647528
- Acronym / sponsor ID
- Chromogenix / Chromogenex Acne
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Jan 2016 (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.
A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Chromogenix Regenlite Transform TreatmentPatients in this arm receive treatment |
| Placebo | Placebo comparator | Device: Chromogenix Regenlite Transform PlaceboPatients in this arm do not receive treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization.
- Healthy male or non-pregnant female 18-65 years-of-age with a clinical diagnosis of mild to moderate facial acne vulgaris.
- Subject must have at least eight and not more than fifty inflammatory facial lesions (i.e., papules/pustules) and no nodules on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area including those present on the nose. Lesions involving the eyes, and scalp should be excluded from the count.
- Subject must be in general good health and free from any clinically significant disease, other than acne, that might interfere with the study evaluations.
- Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
Key exclusion criteria (32 listed)
- Subjects whom are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study.
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of acne.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne.
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 |
|---|---|---|
| Chromogenix Regenlite Transform TreatmentPulse Dyed Laser - 7mm spot size 3-3.6 J/cm2 | Device | Treatment |
| Chromogenix Regenlite Transform PlaceboPulse Dyed Laser - 7mm spot size 0 J/cm2 | Device | Placebo |
Primary outcome
Global Acne Assessment Scoring
Time frame: Through study completion, an average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
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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 Chromogenix Regenlite Transform Treatment in people with Acne Vulgaris, run by Sadick Research Group 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 9 inclusion and 32 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: withdrawn, as of the sponsor's last update on 6 Dec 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Global Acne Assessment Scoring (time frame: Through study completion, an average of 6 months). 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 6 Dec 2016.