Periorbital DisorderNCT04745078
Carboxytherapy for Periorbital Dark Circles
A study testing Caboxy30 and Caboxy60 in people with Periorbital Disorder, run by Alexandria University at 1 site in Egypt.
Trial summary
the study evaluates carboxytherapy for the treatment of periorbital dark circles Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periorbital Disorder
- What is being tested?
- Caboxy30 and Caboxy60
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals with dark circles
Who cannot join
- infections, scarring, pregnancy, allergy, on treatment for the condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Carboxytherapy in Periorbital Dark Circles
the study evaluates carboxytherapy for the treatment of periorbital dark circles
Read the detailed description
two different concentrations of carboxytherapy administered to patients are compared regarding efficacy
- Conditions
- Periorbital Disorder
- Being tested
- Caboxy30, Caboxy60
- Keywords
- carboxytherapy, dark circles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caboxy30Other
Also called Carboxy30
carboxy30 to periorbital dark halos
Caboxy60Other
carboxy60 to periorbital dark halos
| Study group | Role | What they receive |
|---|---|---|
| Carboxy30 | Active comparator | carboxy30 Receives: Other: Caboxy30 |
| Carboxy60 | Active comparator | carboxy60 Receives: Other: Caboxy60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Melanin index
change in melanin index of the dark circles
Measured: 6 weeks
Improvement of erythema index
change in erythema index of the dark circles
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2017
- Primary completion1 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mahmoud, Alexandria University
- Investigators
- Ossama H Roushdy, MD, Study chair, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745078
- Sponsor's protocol ID
- 0104074
- Status last verified
- Nov 2021
- First submitted
- 3 Feb 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Carboxytherapy in Periorbital Dark Circles
- ClinicalTrials.gov ID
- NCT04745078
- Acronym / sponsor ID
- 0104074
- Conditions
- Periorbital Disorder
- Keywords
- carboxytherapy, dark circles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study evaluates carboxytherapy for the treatment of periorbital dark circles
Detailed description
two different concentrations of carboxytherapy administered to patients are compared regarding efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboxy30 | Active comparator | Other: Caboxy30carboxy30 |
| Carboxy60 | Active comparator | Other: Caboxy60carboxy60 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals with dark circles
Key exclusion criteria (1 listed)
- infections, scarring, pregnancy, allergy, on treatment for the condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caboxy30Also: Carboxy30carboxy30 to periorbital dark halos | Other | Carboxy30 |
| Caboxy60carboxy60 to periorbital dark halos | Other | Carboxy60 |
Primary outcome
Improvement of Melanin index
Time frame: 6 weeks
change in melanin index of the dark circles
Improvement of erythema index
Time frame: 6 weeks
change in erythema index of the dark circles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ossama H Roushdy, MD study chair
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caboxy30 and Caboxy60 in people with Periorbital Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Melanin index (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.