PhotoagingNCT03661697
Combination Versus Laser Treatment Only
A study testing Laser Therapy, Basic Skin Care Regimen and Lytera in people with Photoaging, run by University of Miami at 1 site in United States.
Trial summary
Our objective is to determine the effects of (1) basic skin care regimen + "active" (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Laser Therapy, Basic Skin Care Regimen and Lytera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adult male and female patients 18 years and older
- Fitzpatrick skin types I-IV
- Has at least mild mottled skin tone of the face (score of 2 or more on a 5 point skin tone scale)
- Has at least 2 areas of the face with significant roughness, dyspigmentation, or fine lines or has all these characteristics in 1 or more areas
- Willing to refrain from using any other topical products on the face, systemic retinoids, or steroids, facial peels or other facial laser procedures throughout the duration of the study
- Willing to refrain from any cosmetic procedure including but not limited to facial surgery, dermal fillers, and neuromodulators for the duration of the study
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- Willing to use only the facial skin care product regimen provided for the study
- Willing to avoid extended periods of sun exposure and the use of tanning beds during the study
- Willing to have photographs taken of the face to be used de-identified in evaluations, publications, and presentations
- For females: proof that they are not pregnant (urine pregnancy test)
- English-speaker
Who cannot join
- Has any uncontrolled systemic disease (such as autoimmune disorders and connective tissue disorders such as lupus erythematosus or Sjogren's syndrome
- Has any active infection in face
- Has history of any skin conditions that could interfere with treatment
- Has used self-tanner recently
- Is currently participating in another drug research study
- Is NOT willing to refrain from using any other topical products such as skin lightening, retinoids, alpha/beta-hydroxyl acids, salicylic acid, vitamins C or D, steroids, or antibiotics on the face or systemic retinoids, steroids, facial peels, neuromodulators, dermal fillers, facial surgery, or other facial laser procedures throughout the duration of the study
- For females: is pregnant
- Non English-speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study
Our objective is to determine the effects of (1) basic skin care regimen + "active" (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face.
- Conditions
- Photoaging
- Being tested
- Laser Therapy, Basic Skin Care Regimen, Lytera
- Keywords
- skin, sun damage, photoaging of face, skin care, laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Also called Clear and Brilliant Permea (1927nm fractional)
Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high.
All interventions were done at low with four passes to each participant's full face.
Basic Skin Care RegimenOther
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
LyteraOther
cosmeceutical serum applied to face daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lytera Arm | Experimental | 4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments. Receives: Device: Laser Therapy; Other: Basic Skin Care Regimen; Other: Lytera |
| Laser only arm | Active comparator | 4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments. Receives: Device: Laser Therapy; Other: Basic Skin Care Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aesthetics
Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Measured: baseline to 12 weeks
Change in Skin Tone
Change in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start10 Oct 2018
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PhotoagingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Principal investigator, Lisa Grunebaum, University of Miami
- Investigators
- Lisa Grunebaum, MD, Principal investigator, Univeristy of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661697
- Sponsor's protocol ID
- 20171006
- Status last verified
- Apr 2020
- First submitted
- 5 Sep 2018
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study
- ClinicalTrials.gov ID
- NCT03661697
- Acronym / sponsor ID
- 20171006
- Conditions
- Photoaging
- Keywords
- skin, sun damage, photoaging of face, skin care, laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Allergan Sales, LLC
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective is to determine the effects of (1) basic skin care regimen + "active" (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lytera Arm | Experimental | Device: Laser Therapy, Other: Basic Skin Care Regimen, Other: Lytera4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments. |
| Laser only arm | Active comparator | Device: Laser Therapy, Other: Basic Skin Care Regimen4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy adult male and female patients 18 years and older
- Fitzpatrick skin types I-IV
- Has at least mild mottled skin tone of the face (score of 2 or more on a 5 point skin tone scale)
- Has at least 2 areas of the face with significant roughness, dyspigmentation, or fine lines or has all these characteristics in 1 or more areas
- Willing to refrain from using any other topical products on the face, systemic retinoids, or steroids, facial peels or other facial laser procedures throughout the duration of the study
Key exclusion criteria (8 listed)
- Has any uncontrolled systemic disease (such as autoimmune disorders and connective tissue disorders such as lupus erythematosus or Sjogren's syndrome
- Has any active infection in face
- Has history of any skin conditions that could interfere with treatment
- Has used self-tanner recently
- Is currently participating in another drug research study
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 |
|---|---|---|
| Laser TherapyAlso: Clear and Brilliant Permea (1927nm fractional)Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high. All interventions were done at low with four passes to each participant's full face. | Device | Laser only arm, Lytera Arm |
| Basic Skin Care RegimenSkin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks | Other | Laser only arm, Lytera Arm |
| Lyteracosmeceutical serum applied to face daily for 12 weeks | Other | Lytera Arm |
Primary outcome
Change in Aesthetics
Time frame: baseline to 12 weeks
Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Change in Skin Tone
Time frame: baseline to 12 weeks
Change in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lisa Grunebaum, MD principal investigator
Univeristy of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy, Basic Skin Care Regimen and Lytera in people with Photoaging, run by University of Miami 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 11 inclusion and 8 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 24 Apr 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?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Aesthetics (time frame: baseline to 12 weeks). The study lists 2 primary outcomes in all. 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 24 Apr 2020.