N/A
N=22
Clinical Evaluation of the Treatment of Spider Angioma
Spider Angioma
Bottom Line
View on ClinicalTrials.gov: NCT02755467 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Physician's Global Assessment Scale for Improvement of Spider Angioma — 4.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- KTP laser (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Cutera Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician's Global Assessment Scale for Improvement of Spider Angioma |
4.5 | — |
Summary
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
Eligibility Criteria
Inclusion Criteria
- Males or females, 5 to 65 years of age (inclusive).
- Fitzpatrick Skin Types I-IV
- Subject must be able to read, understand and sign the Informed Consent Form.
- If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to have limited sun exposure for the duration of the study, including the follow-up period.
- Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
- Agree not to undergo any other procedure for the treatment of spider angioma during the study.
Exclusion Criteria
- Pregnant.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
- History of seizure disorders due to light.
- Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
- In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
Data sourced from ClinicalTrials.gov (NCT02755467). 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.