- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745078
Carboxytherapy for Periorbital Dark Circles
November 2, 2021 updated by: Heba Mahmoud, Alexandria University
Evaluation of the Use of Carboxytherapy in Periorbital Dark Circles
the study evaluates carboxytherapy for the treatment of periorbital dark circles
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
two different concentrations of carboxytherapy administered to patients are compared regarding efficacy
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Faculty of Medicine,Alexandria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy individuals with dark circles
Exclusion Criteria:
- infections, scarring, pregnancy, allergy, on treatment for the condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Carboxy30
carboxy30
|
carboxy30 to periorbital dark halos
Other Names:
|
Active Comparator: Carboxy60
carboxy60
|
carboxy60 to periorbital dark halos
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Melanin index
Time Frame: 6 weeks
|
change in melanin index of the dark circles
|
6 weeks
|
Improvement of erythema index
Time Frame: 6 weeks
|
change in erythema index of the dark circles
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ossama H Roushdy, MD, University of Alexandria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
May 15, 2021
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 6, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
November 4, 2021
Last Update Submitted That Met QC Criteria
November 2, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0104074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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