NCT04745078

Brief Summary

the study evaluates carboxytherapy for the treatment of periorbital dark circles

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

February 3, 2021

Last Update Submit

November 2, 2021

Conditions

Periorbital Disorder

Keywords

carboxytherapydark circles

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Carboxy30

ACTIVE COMPARATOR

carboxy30

Other: Caboxy30

Carboxy60

ACTIVE COMPARATOR

carboxy60

Other: Caboxy60

Interventions

Caboxy30OTHER

carboxy30 to periorbital dark halos

Also known as: Carboxy30
Carboxy30
Caboxy60OTHER

carboxy60 to periorbital dark halos

Carboxy60

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals with dark circles

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Alexandria University

Alexandria, Egypt

Location

Study Officials

  • Ossama H Roushdy, MD

    University of Alexandria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

January 1, 2017

Primary Completion

April 1, 2021

Study Completion

May 15, 2021

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations

EG(1)