New laser aims to smooth wrinkles and sun damage
NCT ID NCT07214272
First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study is testing a next-generation Fraxel laser system to see how well it improves skin issues like sun damage, lesions, and wrinkles around the eyes. About 49 adults aged 21 to 60 will receive up to three laser treatments. Researchers will check for improvements using a doctor's rating scale and ask participants how satisfied they are with the results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fraxel FTX laser system (a device that uses laser energy to resurface skin)
- What this could lead to
- If successful, this could offer a safe and effective option for improving skin tone, texture, and wrinkles with minimal downtime.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not apply to everyone. Side effects like redness, swelling, or pigment changes are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Oct 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female. 2. 21 to 60 years of age. 3. Written informed consent must be obtained prior to any study procedures. 4. Presence of one or more of the following in the treatment area(s): 1. Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale) 2. Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale). 3. Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale). 5. Ability to read, understand, and sign the informed consent form Exclusion Criteria: 1. Pregnant, breastfeeding, or planning to become pregnant during the study. 2. History of any type of allergic reaction to topical anesthetics. 3. Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study. 4. Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone. 5. Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone. 6. Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment. 7. Predisposition to keloid formation or excessive scarring. 8. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma. 9. Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment. 10. Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study. 11. Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study. 12. Use of systemic retinoids within 6 months prior to enrollment or at any time during the study. 13. Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment. 14. Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study. 15. Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study. 16. Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
La Jolla, California, 92121, United States
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Dermatology and Laser Surgery Center
Houston, Texas, 77004, United States
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Miami Dermatology & Laser Research LLC
Miami, Florida, 33133, United States
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Oak Dermatology, LLC
Naperville, Illinois, 60563, United States
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Union Square Laser Dermatology, P.C
New York, New York, 10003, United States