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Sponsors and Collaborators: |
Carruthers Dermatology Centre Allergan |
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Information provided by: | Carruthers Dermatology Centre |
ClinicalTrials.gov Identifier: | NCT00250952 |
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.
The study was designed to test this thinking, using the crow's feet wrinkles as the treatment area.
Condition | Intervention |
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Skin Wrinkling |
Drug: Botox Cosmetic™ |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Evaluator-Blinded, Two Centre Study of the Safety and Effect of Volume on the Diffusion and Efficacy of BOTOX Cosmetic™ (Botulinum Toxin Type A) in the Treatment of Lateral Orbital Rhytides. |
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | June 2005 |
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.
20 female subjects (10 per site), who fit the inclusion/exclusion criteria for study participation were injected with 5 units of Botox (one injection each side) into the crow's feet area. The injections were prepared with one side randomly receiving a five fold difference in volume for dilution.
Response to treatment was evaluated at 14 days, 30 days, 60 days and 90 days after the injection visit. Standardized photography was taken at each visit.
Analysis of the photographs of the lateral orbital (crow's feet rhytides) at maximum attempted contraction (maximum smile) was done by Canfield Scientific, Inc., using a specialized software program created to detect and measure changes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Skin Care Physicians of Chestnut Hill | |
Chestnut Hill, Massachusetts, United States, 02467 | |
Canada, British Columbia | |
Carruthers Dermatology Centre, Inc. | |
Vancouver, British Columbia, Canada, V5Z 4E1 |
Principal Investigator: | J. Alastair Carruthers, MD | Carruthers Dermatology Centre, Inc. |
Principal Investigator: | Jeffrey S Dover, MD | Skin Care Physicians of Chestnut Hill |
Study ID Numbers: | CCR-001 |
Study First Received: | November 7, 2005 |
Last Updated: | November 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00250952 |
Health Authority: | Canada: Health Canada; United States: Institutional Review Board |
Clinical Practice Variations |
Botulinum Toxins Botulinum Toxin Type A |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |