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Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
NA trial testing Potenza in Wrinkle in 79 participants. Completed in 21 June 2021.
| Lead sponsor | Cynosure, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 3 September 2019 |
| Primary completion | 12 April 2021 |
| Estimated completion | 21 June 2021 |
| Sites | 4 locations across United States |
Cynosure, Inc. — full company profile →
Adults 18 to 55, any sex, with Wrinkle or Fine Lines. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 7 | |
| Treatment With Device | 21 | |
| Treatment With Device | 15 | |
| Treatment With Device | 4 |
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 1 | |
| Treatment With Device | 8 | |
| Treatment With Device | 27 | |
| Treatment With Device | 8 |
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 1 |
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment With Device | 0 |
Time frame: Subject data was collected throughout subject participation in the study, approximately 9 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment With Device |
|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | — |
| Edema | Skin and subcutaneous tissue disorders | — |
| Pinpoint bleeding | Skin and subcutaneous tissue disorders | — |
| Burning sensation | Skin and subcutaneous tissue disorders | — |
| Dryness | Skin and subcutaneous tissue disorders | — |
| Scabbing | Skin and subcutaneous tissue disorders | — |
| Skin Textural Irregularity | Skin and subcutaneous tissue disorders | — |
| Bruising | Skin and subcutaneous tissue disorders | — |
| Pain/tenderness | Skin and subcutaneous tissue disorders | — |
| Tightness | Skin and subcutaneous tissue disorders | — |
| Itching | Skin and subcutaneous tissue disorders | — |
| Streaking | Skin and subcutaneous tissue disorders | — |
| Burn | Skin and subcutaneous tissue disorders | — |
| Petechiae | Skin and subcutaneous tissue disorders | — |
| Acne | Skin and subcutaneous tissue disorders | — |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | — |
| Breakout | Skin and subcutaneous tissue disorders | — |
| Pain | Skin and subcutaneous tissue disorders | — |
| Stabbing sensastion post pinpoint bleeding | Skin and subcutaneous tissue disorders | — |
| Tearing | Eye disorders | — |
| Eye twitch | Eye disorders | — |
| Hypopigmentation | Skin and subcutaneous tissue disorders | — |
| Rash/skin irritation | Skin and subcutaneous tissue disorders | — |
| Histamine | General disorders | — |
| Blanching | Skin and subcutaneous tissue disorders | — |
| Folliculitis | Skin and subcutaneous tissue disorders | — |
| Sensitivity | Skin and subcutaneous tissue disorders | — |
| Pinpoint dots | Skin and subcutaneous tissue disorders | — |
| Tingling | Skin and subcutaneous tissue disorders | — |
| Pustule | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT05097157 adverse events section.
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05097157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing