- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01586819
Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
Treatment of Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A: A Split-face, Rater-blinded Randomized Control Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Illinois
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La Grange Park, Illinois, États-Unis, 60526
- Loyola Dermatology
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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:
- Age 30 to 75 years old
- In good health
- Has static and dynamic lateral canthal wrinkles ("crow's feet")
- Has the willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion Criteria:
- Pregnant or lactating
Has received the following treatments:
- botulinum toxin injections in the past 6 months
- ablative laser procedure in the past 6 months
- radiofrequency device treatment in the past 6 months
- ultrasound device treatment in the past 6 months
- medium to deep chemical peel in the past 6 months
- temporary soft tissue augmentation material in the past year
- semi-permanent soft tissue augmentation material in the past 2 years
- permanent soft tissue augmentation material
- Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures)
- Has an active infection on their face (excluding mild acne
- Has a history of neuromuscular disorders
- Has an allergy to albumin
- Has an allergy to Aquaphor AND petroleum jelly
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Has a mental illness
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Botulinum Toxin
The botulinum toxin will be injected into the wrinkles.
The injections will take about 10 minutes to complete.
Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
|
The botulinum toxin will be injected into the wrinkles "crow's feet".
The injections will take about 10 minutes to complete.
Autres noms:
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Comparateur actif: Chemical Peel Only
After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly. |
After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab.
The mixture will be left in place for a few minutes, and then the face will be wiped clean with water.
Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes.
After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water.
Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment
Délai: Baseline and 12 weeks
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The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides.
The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
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Baseline and 12 weeks
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Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment
Délai: Baseline and 12 weeks
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The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group.
The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
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Baseline and 12 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rebecca Tung, MD, Loyola University
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 (Estimation)
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
- 203555
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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