PhotodamageNCT04519736
Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage - A Split Face Comparison Study
A study testing Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage in people with Photodamage, run by Alma Lasers Inc. at 1 site in United States.
Trial summary
Both the Dye - VL 500 - 600 nm and the Dual band will improve significantly the appearance of Photo Damage with high efficacy including; safety, minimal discomfort and downtime. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Photodamage
- What is being tested?
- Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2014
- Phase
- Interventional
- 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 35 to 60 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- The following are requirements for a potential subject's inclusion into the study:
- Male or female in good general health between 35 to 65 years of age.
- Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit.
- A potential subject must exhibit:
- Clinical diagnosis of photo damage affecting the face.
- For FEMALE PATIENTS OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation.
- Must be willing to comply with study visits and complete the entire course of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participation:
- The following are exclusion criteria for subjects in this study:
- A subject that underwent a laser / light treatment on the face within 12 months, or any topical treatment on the face within 6 months.
- A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
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- A subject using any systemic steroid therapy within 6 months prior to or during the study period.
- A subject that has been treated with Botox/Dysport or filler/biostimulatory molecule injections to his/her face within the past 6 months.
- A subject using any topical medicated creams, lotions, powders, etc. on the treatment areas during the study period, other than the study treatment regimen within 14 days.
- A subject that has previously been treated with systemic retinoids within the past year (e.g., Accutane®, Roche Dermatologics).
- A subject with recently excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing). During the study, when excessive sun exposure is unavoidable, subjects must wear appropriate protective clothing (e.g. hat, collar) and comply with the study dosing regimen of daily application of the dispersed sunblock.
- A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration).
- A female subject who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)].
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
- Subjects who are pregnant, breast-feeding, or planning a pregnancy. Females of childbearing potential, must be either:
- using the same form (i.e. brand) and dosage regimen of an oral contraceptive pill or of a hormonal implant continuously for 3 months prior to study entry and continue during the entire study, or
- willing to use a different form of birth control during the study other than any form of hormonal methods such as oral contraceptive pills and hormonal implants 30 day prior to study entry and during the entire study period. For the purpose of this study, the following are also considered acceptable methods of birth control: double-barrier methods (e.g.: condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually active.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Laser & Surgery Specialists of NY/NJ
Hackensack, New Jersey, 07601
About this study
Official title: Single Band (Alma) vs. Dual Band (Palomar) Pulsed Light Technology for the Treatment of Photodamage - a Split Face Comparison Study
Both the Dye - VL 500 - 600 nm and the Dual band will improve significantly the appearance of Photo Damage with high efficacy including; safety, minimal discomfort and downtime.
- Conditions
- Photodamage
- Being tested
- Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage
- Keywords
- Hyperpigmentation, Telangiectasias
- Medical subject headings
- Hyperpigmentation, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Band vs. Dual Band Pulsed Light Technology for the Treatment of PhotodamageDevice
| Study group | Role | What they receive |
|---|---|---|
| Harmony Dye-VL 500-600nm | Active comparator | The left side of the face will be treated with the Single Band Alma Harmony Dye-VL 500-600nm device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . Receives: Device: Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage |
| Palomar MaxG | Active comparator | Right side of the face will be treated with the Dual Band Palomar MaxG device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . Receives: Device: Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photodamage
Investigator Evaluation of Specific Signs of Photo Damage
The investigator will evaluate the clinical improvement from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following Global Assessment scale (compared to baseline photographs):
Global Aesthetic Improvement Scale (GAIS ) Rating Description
- = Very much improved 75%-99%
- = Much improved 50%-75% 3= Improved 25%-50% 4= No change 1%-25% 5=Worse <1%
Measured: The investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments and before follow-up visit (3 months after the last treatment)
Secondary outcomes (1)
Photodamage
Investigator Evaluation of Specific Signs of Photo Damage
In addition, the Investigator will at each visit complete the Investigator Evaluation of Specific Signs of Photo Damage as seen below (for each of the handpieces):
Poilikoderma of Civatte
- None (0) = Normal
- Trace (1) = Barely visible and localized
- Mild (2) = Somewhat visible and diffuse
- Moderate (3) = Visible and diffuse
- Severe (4) = Extremely visible and dense
Telangiectasias
- None (0) = Normal
- Trace (1) = Barely visible and localized
- Mild (2) = Somewhat visible and diffuse
- Moderate (3) = Visible and diffuse
- Severe (4) = Extremely visible and dense
Pigmented components of Photo Damage
- None (0) = Normal
- Trace (1) = Barely visible and localized
- Mild (2) = Somewhat visible and diffuse
Measured: Investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments, and before follow up visit (three months after the last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotodamageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519736
- Sponsor's protocol ID
- ALMA-500600-PL12DG
- Status last verified
- Apr 2013
- First submitted
- 7 Jan 2014
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Band (Alma) vs. Dual Band (Palomar) Pulsed Light Technology for the Treatment of Photodamage - a Split Face Comparison Study
- ClinicalTrials.gov ID
- NCT04519736
- Acronym / sponsor ID
- ALMA-500600-PL12DG
- Conditions
- Photodamage
- Keywords
- Hyperpigmentation, Telangiectasias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Aug 2020 (actual)
- 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.
Both the Dye - VL 500 - 600 nm and the Dual band will improve significantly the appearance of Photo Damage with high efficacy including; safety, minimal discomfort and downtime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmony Dye-VL 500-600nm | Active comparator | Device: Single Band vs. Dual Band Pulsed Light Technology for the Treatment of PhotodamageThe left side of the face will be treated with the Single Band Alma Harmony Dye-VL 500-600nm device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . |
| Palomar MaxG | Active comparator | Device: Single Band vs. Dual Band Pulsed Light Technology for the Treatment of PhotodamageRight side of the face will be treated with the Dual Band Palomar MaxG device. Three treatments, administered in intervals of 21 +/- 2 days. Each full face treatment duration will be approximately 20-30 minutes . |
Who may qualify
- Ages
- 35 to 60 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female in good general health between 35 to 65 years of age.
- Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit.
- A potential subject must exhibit:
- Clinical diagnosis of photo damage affecting the face.
- For FEMALE PATIENTS OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation.
Key exclusion criteria (17 listed)
- A subject that underwent a laser / light treatment on the face within 12 months, or any topical treatment on the face within 6 months.
- A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
- A subject using any systemic steroid therapy within 6 months prior to or during the study period.
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 |
|---|---|---|
| Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage | Device | Harmony Dye-VL 500-600nm, Palomar MaxG |
Primary outcome
Photodamage
Time frame: The investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments and before follow-up visit (3 months after the last treatment)
Investigator Evaluation of Specific Signs of Photo Damage The investigator will evaluate the clinical improvement from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following Global Assessment scale (compared to baseline photographs): Global Aesthetic Improvement Scale (GAIS ) Rating Description 1. = Very much improved 75%-99% 2. = Much improved 50%-75% 3= Improved 25%-50% 4= No change 1%-25% 5=Worse <1%
1 secondary outcome
Photodamage
Time frame: Investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments, and before follow up visit (three months after the last visit)
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 Aug 2020.
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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 study testing Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage in people with Photodamage, run by Alma Lasers 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 7 inclusion and 17 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 Aug 2020. 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.
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?
Photodamage (time frame: The investigator will evaluate the change in visual appearance of the treated area at 3 week, 6 week, 9 week treatments and before follow-up visit (3 months after the last treatment)). 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 Aug 2020.