N/A
Completed N=42
755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
Benign Pigmented and Vascular Lesions and Scars
Source: ClinicalTrials.gov NCT01745627 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Clearance Based on Photographic Scale — 2; 2; 4; 7 Participants
Summary
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance Based on Photographic Scale |
2; 2; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects between 18 and 85 years of age.
- Subjects with Fitzpatrick skin types I to VI.
- Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
- Subject who are willing to consent to participate in the study.
4.2 Exclusion Criteria
- Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
- Hypersensitive to light exposure.
- Active localized or systemic infections.
- Taking medication for which sunlight is a contraindication.
- History of squamous cell carcinoma or melanoma.
- History of keloid scarring.
- Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- Prior treatment with laser or other devices in treatment area within 3 months
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
- Subjects that the physician determines ineligible based on standard of care treatment.
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Data sourced from ClinicalTrials.gov (NCT01745627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.