Évaluation d'un dispositif de microcourant + cryothérapie
Une étude randomisée croisée de 8 semaines pour évaluer l'efficacité d'un dispositif de microcourant + cryothérapie
The present study aims to assess use of a microcurrent and cryotherapy device on skin health over an 8-week period using an at-home device that provides 15-minutes of microcurrent + cold therapy once daily. An additional aim is to assess the acute (i.e., single) use of microcurrent or microcurrent + cold therapy on measures of skin health. The primary question it seeks to answer is whether daily use of the TheraFace Pro Gen 2 alters facial skin characteristics. Secondary aims include collecting clinical images, professional photographs, and consumer perceptions of the device.
Participants between the ages of 25-65 with various skin types will be enrolled for participation. Participants will visit the clinic three times for collection of outcome metrics at baseline with microcurrent therapy, baseline 2 using microcurrent + cold therapy, and 8 weeks after baseline. Measurements include: expert clinical grading, digital imaging, subjective assessment of skin, and clinical grade-images.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
At home treatments to minimize and/or reverse the effects of skin aging has been gaining popularity over time. Two treatments commonly used in spa-settings to achieve these goals are microcurrent therapy and cold-therapy. Microcurrent therapy is a gentle skin treatment that uses low-level voltage to stimulate the facial muscles. This low-level voltage is applied during microcurrent facials to help tone and firm the skin by causing subtle muscle contractions. Localized cold therapy helps reduce inflammation by narrowing blood vessels and decreasing blood flow to the treated area. The central aim of this study is to investigate both acute and chronic (8 weeks) use of an at-home device that delivers both microcurrent and cold therapy on skin health. Participants will complete two acute baseline visits in randomized order, microcurrent alone and microcurrent + cold therapy in order to assess the acute effects of this therapy. Participants will then complete 8-weeks of microcurrent + cold therapy lasting about 8 minutes/day using the Therabody TheraFace Pro Gen 2 at home. Outcome measures include expert assessment and participant subjective health of skin of the face.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New Jersey
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Teaneck, New Jersey, États-Unis, 07666
- Validated Claim Support
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject is female or male (approximately 85% female and 15% male)
- Subject is between the ages of 25-65 (no more than 25% 55-65 per group)
- Individuals with fine lines/wrinkles, lack of firmness, dullness, and uneven skin tone with a grade of at least 3 on a 10-point scale.
- Individuals with sensitive skin.
- Individuals who are able to cooperate with the Principal Investigator and study personnel throughout the duration of the study and are willing to comply with all study procedures, methods, evaluations, and study product use.
- Individuals who are able to read and sign and informed consent.
- Individuals who are able to receive emails on their cellular phones and are capable of completing electronic Informed Consents and/or Questionnaires on their device.
- Individuals willing to be photographed and sign a model release.
Exclusion Criteria:
- Individuals who have had Botox in the last 3 months prior to Baseline.
- Individuals who have had Filler (Including Lip Filler) in the last 6 months prior to Baseline.
- Individuals with a history of atopic eczema, psoriasis, or onychomycosis.
- Individuals who have used a topical or system medication within 14 days prior to Baseline.
- Individuals who are on anti-acne drugs, topical and/or oral retinoids.
- Individuals currently on GLP1 medications or other weight loss regimens.
- Individuals who have used a beauty device of any kind in a clinical testing facility in the past 5 months prior to Baseline.
- Individuals who have used self-tanners and/or tanning beds within 14 days prior to Baseline.
- Individuals currently participating in other clinical studies that are testing a face product and/or device.
- Individuals with uncontrolled medical condition(s), including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise the study outcome and/or chronic or serious diseases and conditions which would prevent participation in this clinical study such as cancer, AIDS, insulin-dependent diabetes, renal impairment, mental illness, and/or drug/alcohol addiction.
- Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
- Individuals who are pregnant, lactating, or planning to become pregnant. -Individuals who become pregnant during the study must inform the Principal Investigator immediately.
- Individuals who are unreliable or unlikely to be available for the duration of the study.
- Individuals with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic and personal care products/ingredients.
- Individuals who are immunocompromised.
- Individuals who are employees of VCS, other testing firms/laboratories, consumer products, and/or raw goods manufacturers/suppliers.
- Individuals who are unable to communicate or cooperate with the Principal Investigator/study personnel due to language problems, poor mental development, or impaired cerebral function.
- Individuals who started hormones within the last three months preceding the commencement of the study.
- Individuals who are using oral contraception for less than three months before study commencement or who have changed their contraceptive method within the three months before the Baseline visit or planning to modify their contraception treatment within the duration of the study.
- Individuals who have regular salon and/or dermatological procedures that can interfere with study results (Microdermabrasion, Fillers, Facial Peels, etc.) and are not willing to stop throughout the study.
- Individuals with facial tattoos and facial piercings (that can't be removed).
- Individuals with tattooed/permanent make up (i.e., eyeliner, eyebrows, lip liner, etc.), eyebrow microblading, and/or eyelash extensions.
- Individuals who plan to change their hairstyle throughout the course of the study or who wear hair coverings regularly (i.e., wigs, coloring, extensions, etc.).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Acute Application of Microcurrent by Esthetician
A licensed esthetician will complete an 18-step routine on the right and left side of the face including: lower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). |
The esthetician will apply only the microcurrent setting during the 18-step routine. The esthetician will apply cold + microcurrent therapy during the 18-step routine. |
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Expérimental: Chronic Use of Microcurrent + Cold Therapy
All evaluations will occur after sitting in 15-minutes of ambient conditions. Participants will be instructed to use the TheraFace Pro Gen 2 for approximately 8 minutes a day following an 18-step routine on each side of the face. The steps include: ower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). Each location will receive ~10 seconds of treatment. |
Participants will be instructed to use the TheraFace Pro Gen 2 for approximately 8 minutes a day following an 18-step routine on each side of the face. The steps include: ower neck (glide), upper neck (glide), vertical neck (glide), neck contour (glide), neck contour (press + hold), jawline cradle (glide), jawline cradle (press + hold), jaw contour (glide), jaw contour (press + hold), cheek contour (glide), cheek contour (press + hold), cheekbone contour (glide), cheek contour (press + hold), brow lift (glide), brow lift (press + hold), eye contour (glide), eye contour (press + hold), inner brow (glide), & inner brow (press + hold). Each location will receive ~10 seconds of treatment. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Expert grading
Délai: 8-weeks
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Expert clinical grading will be used to measure a variety of skin health appearance measures including: fine lines/wrinkles, firmness, elasticity, radiance plumping (lips), contour (cheeks), pore appearance, lift (mid-face and jowls), nasolabial folds, and skin tone evenness. These will be graded on a scale from 0 to 10, with 0 representing a positive outcome (i.e., no wrinkles) and 10 representing a negative outcome (i.e., numerous, deep wrinkles). These will be assessed by an expert grader. |
8-weeks
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Cutometer
Délai: 8 weeks
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The Cutometer MPA 580 measures the viscoelastic properties of the skin using suction and a probe to determine the penetration depth using an optical measuring system. The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue). Elasticity will be reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness will be reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease. R0 (elasticity) and R5 (firmness) will be the only two parameters provided. |
8 weeks
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VISIA CR Imaging
Délai: 8 weeks
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The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of lighting conditions (Standard 1, Raked, Cross Polarized, and Primos 3D) to assess wrinkle depth and texture. Images will be taken of the face, utilizing the following angles: 45 degrees right, straight on, and 45 degrees left with the following lighting conditions: Standard 1, Raked, Cross Polarized, and Primos 3D. Analysis is performed by Canfield. The VISIA-CR provides a percentile value compared to others with similar skin (the higher the better); the feature count (the lower the better) and the absolute score (the lower the better). |
8 weeks
|
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Clinical Photography
Délai: 8 weeks
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Clinical photography involves analysis of high-resolution images taken at different angles (45 degrees right, straight on, 45 degrees left) to compare in a side-by-side format at each time point. Images at each time point will be compared to highlight key changes in skin condition. |
8 weeks
|
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Participant perceptions of skin health
Délai: 8 weeks
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Participants will complete subjective questionnaires ranking the impact of the treatment on overall skin health measures, including: finelines, facial puffiness, bounce, resiliency, sculpting of jawline, firmness, lift, plumping (lips), texture, comfort, plumpness, facial contour, rejuvenation, skin tone, sagging skin, and liveliness. Participants will also rank enjoyment, convenience, ease of use, and comfort of device usage. All measures will be ranked on a 5-point Likert scale, with 0 indicating strongly disagree and 5 indicating strongly agree. |
8 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PR251054.V03
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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