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Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of 3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their facial skin appearance.
Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least 50% of the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M22 IPL and ResurFX | Experimental | The procedure will include an intense pulse light (IPL) treatment followed by fractional non-ablative (FNA) treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M22 IPL and ResurFX | Device | The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES) | Skin improvement by Fitzpatrick Elastosis Scale (FES) or category scale at 3 months based on before/after photos | 3 months following 3rd treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with ≥ 50% improvement in Fitzpatrick Elastosis Scale (FES) | Overall skin improvement at 1 and 6 months by subject and investigator evaluation compared to baseline using the category global aesthetic improvement (GAI) scale | 1 and 6 months following 3rd treatment |
| Change in erythema/ edema/ purpura and the response intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Dermatology Institute | Orlando | Florida | 32801 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30091207 | Derived | Knight JM, Kautz G. Sequential facial skin rejuvenation with intense pulsed light and non-ablative fractionated laser resurfacing in fitzpatrick skin type II-IV patients: A prospective multicenter analysis. Lasers Surg Med. 2019 Feb;51(2):141-149. doi: 10.1002/lsm.23007. Epub 2018 Aug 8. |
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Immediate response (erythema, edema, purpura, etc.) of the skin will be assessed within 20-30 min post treatment by a 5 level scale: (0) None / (1) Trace / (2) Mild / (3) Moderate / (4) Severe. |
| Following treatments- Baseline, 4, 8 weeks |
| Downtime in days | Downtime defined as the period of time following the procedure during which the subject felt unable/unwilling to go out in public due to edema and / or erythema. | Following treatment- baseline, 4, 8 weeks |
| Subject Comfort using a Pain Visual Analogue Scale (VAS) | Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain". | Following treatment- baseline, 4, 8 weeks |
| Subject subjective assessment of improvement using categorical improvement scales | Subject subjective opinion of improvement and satisfaction with the treatment using the global aesthetic improvement (GAI) scale and pigment Improvement score. | Following treatments- 4, 8 weeks and 1, 3 and 6 months follow up |
| Number of Participants with Adverse Events | Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events. | Following treatment #1, 2 and 3 and all follow up visits |
| Konz |
| Rhineland-Palatinate |
| 54329 |
| Germany |