Radiation ToleranceNCT00818311
Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in Healthy Subjects
A study testing LED GentleWaves® in people with Radiation Tolerance and Skin Aging, run by L'Oreal at 1 site in United States.
Trial summary
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Tolerance, Skin Aging, Rhytids
- What is being tested?
- LED GentleWaves®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (male and female) at least 18 years old with skin types range from Fitzpatrick type I-VI (Appendix 1),
- Subjects must read, understand and sign the informed consent,
- Subjects must be willing and able to comply with follow up requirements,
- To be willing to report any medications taken during the study and refrain from taking any medication during the study that might produce photoreactions.
Who cannot join
- Subjects must not have active or localized or systemic infection,
- Subjects must not be immunocompromised,
- Subjects must be negative for HIV and hepatitis B and C serology,
- Subjects must not have history of light activated seizure or migraine headache disorder,
- Individuals taking medication who have been advised by a physician or pharmacist to avoid sunlight and subjects having vitiligo
- Subjects must not have mental illness such as schizophrenia or severe depression,
Show all 13Show fewer
- Subjects must not have photosensitivity, photoallergy or photodermatitis,
- Subjects must not be pregnant or breast feeding. Subjects must discuss concerns about birth control with the study physician. Subjects who become pregnant during the study must inform the investigator immediately,
- Subject must not have a skin condition that the examining Investigator deems inappropriate for participation,
- Subject must not take part or intend to take part in another study liable to interfere with this study whatever the region of the body considered for 30 days prior to the study start and 30 days following completion of the study,
- Subjects must not have had GentleWaves treatment, other light treatments (including tanning beds), collagen or other facial tissue augmentation, Botox®, chemical peels, non-ablative (non invasive laser) therapies, dermabrasion, topical antioxidant or other resurfacing procedures at any time during the study,
- Subject must not refuse to sign the informed consent document and/or refuse to comply with all study requirements,
- Subjects must not have any previous history of keloïd scarring.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Stephens and Associates, Inc
Carrollton, Texas, 75006
About this study
Official title: Evaluation of the Effect of Photomodulation on Skin Safety Profile Following Different Schedules of Exposure to the Light Emitting Diode LED (Gentlewaves®) in Randomized Healthy Subjects
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. The photomodulation concept includes a low energy, narrow band or coherent light with specific pulse sequences and durations.
Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light sources, his group has demonstrated that by varying light pulses and other parameters, procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles and an increase of collagen synthesis versus control with little or no side effects associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005; 20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body certification for the same indication. This medical claim is associated with cosmetic improvement of aging and sun-damaged skin, further validation the science of LED photomodulation skin rejuvenation [Investigator's Brochure. Version 1].
Read more
This approval has been obtained with a professional LED GentleWaves® device used under a physician's responsibility. The initial regimen of 35 seconds twice per week with at least two days in between treatment for a total of 4 weeks duration of treatment has demonstrated efficacy for the treatment of typical signs of photo aging and no adverse effect.
A monocentre, randomized clinical study.
Read the detailed description
The purpose of this study is to evaluate different treatment regimens in order to be able to develop new indications or to optimize the result already obtained in the treatment of wrinkles around the eyes. We therefore propose to perform a safety clinical trial with male and female volunteers with different schedules per day or per week.
A total of 100 subjects (male and female) will be randomized in the study according to the following schedule of exposure:
Group A: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for one cycle (35 seconds) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group B: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for two consecutive cycles (35 seconds each) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group C: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) twice a day (morning and evening). This treatment will be repeated twice a week with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks.
treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks.
- Conditions
- Radiation Tolerance, Skin Aging, Rhytids
- Being tested
- LED GentleWaves®
- Keywords
- Light emitting diode, tolerance, photomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED GentleWaves®Device
Also called Gentle Waves professional base unit, The control unit consists of an LCD with the control electronics., • primary spectral radiance with dominant 590 nm, • irradiance power level 4mW/cm2,
primary spectral radiance with a dominant 590 nm wavelength (yellow visible light), irradiance power level of 4mW/cm2, Light pulsed with sequential period on/off for a total duration of 35 seconds per cycle.
| Study group | Role | What they receive |
|---|---|---|
| 5 | Other | Not described Receives: Device: LED GentleWaves® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the skin tolerance
Measured: 10
Secondary outcomes (1)
Photography An overall global evaluation 2 biopsies
Measured: 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToleranceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James H Herndon, MD, Principal investigator, Thomas Stephens and Associates, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818311
- Sponsor's protocol ID
- C08-D-121
- Other IDs
- 2008/US/LED/003
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2009
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Photomodulation on Skin Safety Profile Following Different Schedules of Exposure to the Light Emitting Diode LED (Gentlewaves®) in Randomized Healthy Subjects
- ClinicalTrials.gov ID
- NCT00818311
- Acronym / sponsor ID
- C08-D-121
- Conditions
- Radiation Tolerance, Skin Aging, Rhytids
- Keywords
- Light emitting diode, tolerance, photomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2009 (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.
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. The photomodulation concept includes a low energy, narrow band or coherent light with specific pulse sequences and durations.
Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light sources, his group has demonstrated that by varying light pulses and other parameters, procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles and an increase of collagen synthesis versus control with little or no side effects associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005; 20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body certification for the same indication. This medical claim is associated with cosmetic improvement of aging and sun-damaged skin, further validation the science of LED photomodulation skin rejuvenation [Investigator's Brochure. Version 1].
This approval has been obtained with a professional LED GentleWaves® device used under a physician's responsibility. The initial regimen of 35 seconds twice per week with at least two days in between treatment for a total of 4 weeks duration of treatment has demonstrated efficacy for the treatment of typical signs of photo aging and no adverse effect.
A monocentre, randomized clinical study.
Detailed description
The purpose of this study is to evaluate different treatment regimens in order to be able to develop new indications or to optimize the result already obtained in the treatment of wrinkles around the eyes. We therefore propose to perform a safety clinical trial with male and female volunteers with different schedules per day or per week.
A total of 100 subjects (male and female) will be randomized in the study according to the following schedule of exposure:
Group A: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for one cycle (35 seconds) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group B: 20 subjects (8 males - 12 females) will be exposed to the LED twice a week for two consecutive cycles (35 seconds each) with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group C: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) twice a day (morning and evening). This treatment will be repeated twice a week with an interval between treatments of at least 2 days, during a treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks.
treatment period of 4 weeks.
Group D: 20 subjects (8 males - 12 females) will be exposed to the LED for one cycle (35 seconds) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Group E: 20 subjects (8 males - 12 females) will be exposed to the LED for two consecutive cycles (35 seconds each) every day (from Monday to Friday) during a treatment of period of 4 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 | Other | Device: LED GentleWaves® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects (male and female) at least 18 years old with skin types range from Fitzpatrick type I-VI (Appendix 1),
- Subjects must read, understand and sign the informed consent,
- Subjects must be willing and able to comply with follow up requirements,
- To be willing to report any medications taken during the study and refrain from taking any medication during the study that might produce photoreactions.
Key exclusion criteria (13 listed)
- Subjects must not have active or localized or systemic infection,
- Subjects must not be immunocompromised,
- Subjects must be negative for HIV and hepatitis B and C serology,
- Subjects must not have history of light activated seizure or migraine headache disorder,
- Individuals taking medication who have been advised by a physician or pharmacist to avoid sunlight and subjects having vitiligo
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 |
|---|---|---|
| LED GentleWaves®Also: Gentle Waves professional base unit, The control unit consists of an LCD with the control electronics., • primary spectral radiance with dominant 590 nm, • irradiance power level 4mW/cm2,primary spectral radiance with a dominant 590 nm wavelength (yellow visible light), irradiance power level of 4mW/cm2, Light pulsed with sequential period on/off for a total duration of 35 seconds per cycle. | Device | 5 |
Primary outcome
Assess the skin tolerance
Time frame: 10
1 secondary outcome
Photography An overall global evaluation 2 biopsies
Time frame: 10
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 7 Jan 2009.
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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.
James H Herndon, MD principal investigator
Thomas Stephens and Associates, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED GentleWaves® in people with Radiation Tolerance and Skin Aging, run by L'Oreal 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 13 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 7 Jan 2009. 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?
Assess the skin tolerance (time frame: 10). 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 7 Jan 2009.