PhotodamageNCT04519723
Laser 360iQ: Optimal Light-laser Combination Therapy
A study testing Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination . in people with Photodamage, run by Alma Lasers Inc. at 1 site in United States.
Trial summary
To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photodamage
- What is being tested?
- Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female in good general health between 35 to 60 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:
- Facial wrinkling and graded mild to moderate overall rough texture, large pores, and/or skin laxity.
- 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.
- Negative urine pregnancy test results at the time of study entry (if applicable).
- Must be willing to comply with study visits and complete the entire course of the study.
Who cannot join
- Negative urine pregnancy test results at the time of study entry (if applicable).
- Must be willing to comply with study visits and complete the entire course of the study.
- Subjects meeting any of the following criteria will be excluded from participation:
- The following are exclusion criteria for subjects in this study:
- 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.
Show all 18Show fewer
- 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.
- A subject that has been treated with Botox/Dysport or filler/biostimulatory molecule injections to his/her face within the past six 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) 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, in addition to having a negative pregnancy test at the screening visit, 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 three 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 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.
About this study
Official title: Laser 360iQ: Optimal Light-laser Combination Therapy for the Improvement of Skin Color, Tone, Texture and Laxity.
To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity
Read the detailed description
This is a prospective study to test the safety and efficacy of a three different light and laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full face treatment duration will be approximately 60 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated. The treatment area will be cleaned and photographed before each treatment. Photographs will be taken at baseline, prior to each treatment and during each follow-up visit. Before the initiation of the first treatment each subject will undergo clinical evaluation.
Clinical improvement will be assessed by the investigator from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Treatments and results will be documented in a Case Report Form at each treatment session and follow-up session (1 month and 3 months after the last treatment). In case of adverse side effects and symptoms other than erythema or edema appear during or following a treatment, the next treatment may be skipped by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects are observed, the investigator should provide the subject with the proper care and remedy and will document it in the Case Report Form.
- Conditions
- Photodamage
- Being tested
- Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .
- 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.
Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .Device
| Study group | Role | What they receive |
|---|---|---|
| Alma Harmony Laser System | Other | There is only one arm. Three hand modules; Dye-VL 500-600nm, High Power QSW 1064nm, and High power Pixel ER:YAG 2940nm laser module with rollers will be utilized in combination in a series of treatments intended to improve skin color, tone, texture and laxity. Subjects will receive up to four treatments administered in intervals of 28 +/- 2 days. Treatment duration of approximately 60 minutes. Receives: Device: Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual observation of improvement in photoaging
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 before one month, two month, and three month treatments and before each follow-up visit (1 month and 3 months after the last treatment).
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 startFeb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Zelickson, MD, Principal investigator, Board Certified Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519723
- Sponsor's protocol ID
- XYZ-12345-2012
- Status last verified
- Apr 2012
- 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
- Laser 360iQ: Optimal Light-laser Combination Therapy for the Improvement of Skin Color, Tone, Texture and Laxity.
- ClinicalTrials.gov ID
- NCT04519723
- Acronym / sponsor ID
- XYZ-12345-2012
- Conditions
- Photodamage
- Keywords
- Hyperpigmentation, telangiectasias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 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.
To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity
Detailed description
This is a prospective study to test the safety and efficacy of a three different light and laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full face treatment duration will be approximately 60 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated. The treatment area will be cleaned and photographed before each treatment. Photographs will be taken at baseline, prior to each treatment and during each follow-up visit. Before the initiation of the first treatment each subject will undergo clinical evaluation.
Clinical improvement will be assessed by the investigator from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Treatments and results will be documented in a Case Report Form at each treatment session and follow-up session (1 month and 3 months after the last treatment). In case of adverse side effects and symptoms other than erythema or edema appear during or following a treatment, the next treatment may be skipped by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects are observed, the investigator should provide the subject with the proper care and remedy and will document it in the Case Report Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alma Harmony Laser System | Other | Device: Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .There is only one arm. Three hand modules; Dye-VL 500-600nm, High Power QSW 1064nm, and High power Pixel ER:YAG 2940nm laser module with rollers will be utilized in combination in a series of treatments intended to improve skin color, tone, texture and laxity. Subjects will receive up to four treatments administered in intervals of 28 +/- 2 days. Treatment duration of approximately 60 minutes. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female in good general health between 35 to 60 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:
- Facial wrinkling and graded mild to moderate overall rough texture, large pores, and/or skin laxity.
- 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 (18 listed)
- Negative urine pregnancy test results at the time of study entry (if applicable).
- Must be willing to comply with study visits and complete the entire course of the study.
- 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.
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 |
|---|---|---|
| Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination . | Device | Alma Harmony Laser System |
Primary outcome
Visual observation of improvement in photoaging
Time frame: The investigator will evaluate the change in visual appearance of the treated area before one month, two month, and three month treatments and before each follow-up visit (1 month and 3 months after the last treatment).
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%
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.
Related trials for Photodamage
Not yet recruiting
Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .
Photodamage of the Face, Anti Aging
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.
Brian Zelickson, MD principal investigator
Board Certified Dermatologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination . 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 18 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?
Visual observation of improvement in photoaging (time frame: The investigator will evaluate the change in visual appearance of the treated area before one month, two month, and three month treatments and before each follow-up visit (1 month and 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; AzTrials last refreshed its copy on 28 Oct 2026.