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Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenerating Skin Nectar (by Alastin) + Tegaderm | Active Comparator | Alastin to be applied post procedure followed up Tegaderm. Tegaderm will be left on for 12 hours. Alastin will be applied twice daily for the duration of the study |
|
| Kerra+ Recovery Cream (by Quthero) + Tegaderm | Active Comparator | Patients will receive Kerra+ post procedure followed by Tegaderm. The Tegaderm is removed after 12 hours. Kerra+ will be applied twice daily for the duration of the study. |
|
| Ariessence Platelet-Derived Growth Factor (PDGF) solution +Alastin + Tegaderm | Active Comparator | Patients will receive PDGF immediately post procedure followed by Alastin followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Alastin will continue to be applied twice daily for the duration of the study |
|
| Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm | Active Comparator | Patients will receive PDGF immediately post procedure followed by Kerra+ followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Kerra+ will continue to be applied twice daily for the duration of the study |
|
| Tegaderm Only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ellacor Micro-Coring Technology | Device | ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65. |
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| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician. | GAIS Assessment will be performed under a timeframe of 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Assessment | Clinical assessment will be performed, and graded on a 0-3 scale on Day 0, Day 7, Day 30, and Day 90- 0 = absent, 1 = mild, 2 = moderate, 3 = severe for the following side effects:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes | Safety will be evaluated throughout the duration of the study by recording adverse events on Day 0, Day 7, Day 30, and Day 90 | Day 0 to end of study period |
| Subject Satisfaction Survey |
Inclusion Criteria:
Exclusion Criteria:
i. Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus e. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) f. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days g. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area h. Patients have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old i. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months j. Patients with scars less than six (6) months old in the treatment area k. During the study time frame, unwilling to refrain from receiving these following aesthetic treatments: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.); l. Have enrolled in another clinical trial during or overlapping part of this study m. Unwilling to have facial photography taken for the study purpose n. Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from performing the procedure correctly.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology And Laser Institute | Miami | Florida | 33173 | United States | ||
| Caloaesthetics Plastic Surgery Center |
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| Active Comparator |
Patient will only receive Tegaderm for post-care |
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| Clinical assessment will be performed at each follow up throughout the study period. |
Subject satisfaction data will be collected via a written questionnaire at the 90-day post procedure final follow-up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied nor satisfied; 4) somewhat satisfied; 5) very satisfied.
| Day 90 |
| Louisville |
| Kentucky |
| 42022 |
| United States |