Carboxytherapy for Periorbital Dark Circles | NCT04745078

Studies
Carboxytherapy for Periorbital Dark Circles

NCT04745078

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Nov 4, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Periorbital Disorder

Interventions

Caboxy30
Caboxy60

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Feb 3, 2021

First Submission Date that Met QC Criteria

Feb 6, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2021

Last Update Posted Date

Nov 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carboxy30	Active Comparator	carboxy30	Other: Caboxy30
Carboxy60	Active Comparator	carboxy60	Other: Caboxy60

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caboxy30	Other	carboxy30 to periorbital dark halos	Carboxy30	Carboxy30

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of Melanin index	change in melanin index of the dark circles	6 weeks
Improvement of erythema index	change in erythema index of the dark circles	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals with dark circles

Exclusion Criteria:

infections, scarring, pregnancy, allergy, on treatment for the condition.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ossama H Roushdy, MD	University of Alexandria	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine,Alexandria University		Alexandria			Egypt