FrecklesNCT01545869
Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.
A study testing Fractional carbon dioxide laser in people with Freckles, run by Cairo University at 1 site in Egypt.
Trial summary
Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Freckles
- What is being tested?
- Fractional carbon dioxide laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Oct 2012
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patients affected with facial freckles.
- Age: 10 years or more
Who cannot join
- Patients younger than 10 years old.
- Patients aged 10-21 years who can not provide a written consent of parents or legal guardian.
- Patients with known tendency to keloid or hypertrophic scar formation.
- Patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology department - faculty of medicine- Cairo University
Cairo
About this study
Official title: Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types.
The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid 1990s. The traditional CO2 laser was very effective, however it fell out of favor because it required general anesthesia. It also had a prolonged recovery time. Over the last several years, advances in technology known as fractional resurfacing has made the CO2 laser popular again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional CO2 laser in treatment of freckles could be retrieved.
- Conditions
- Freckles
- Being tested
- Fractional carbon dioxide laser
- Keywords
- carbon dioxide laser, fractional resurfacing, freckles, melanosis
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional carbon dioxide laserProcedure or surgery
Also called Ablative fractional laser resurfacing
SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.
| Study group | Role | What they receive |
|---|---|---|
| Fractional carbon dioxide laser | Experimental | Not described Receives: Procedure: Fractional carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success
reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos
Measured: One month
Secondary outcomes (1)
Treatment safety
Absence of irreversible changes in color and texture of the facial skin, that can cause patient dissatisfaction
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrecklesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Bakr Mohamed Elzawahry, Cairo University
- Investigators
- Bakr M Elzawahry, MD, Study chair, Cairo UniversityVanessa G Hafez, MD, Principal investigator, Cairo UniversityAya Fahim, MBBCh, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545869
- Sponsor's protocol ID
- Fractional CO2 in freckles
- Status last verified
- Apr 2014
- First submitted
- 2 Mar 2012
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
- ClinicalTrials.gov ID
- NCT01545869
- Acronym / sponsor ID
- Fractional CO2 in freckles
- Conditions
- Freckles
- Keywords
- carbon dioxide laser, fractional resurfacing, freckles, melanosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- 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.
Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types.
The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid 1990s. The traditional CO2 laser was very effective, however it fell out of favor because it required general anesthesia. It also had a prolonged recovery time. Over the last several years, advances in technology known as fractional resurfacing has made the CO2 laser popular again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional CO2 laser in treatment of freckles could be retrieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional carbon dioxide laser | Experimental | Procedure: Fractional carbon dioxide laser |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- -Patients affected with facial freckles.
- Age: 10 years or more
Key exclusion criteria (4 listed)
- Patients younger than 10 years old.
- Patients aged 10-21 years who can not provide a written consent of parents or legal guardian.
- Patients with known tendency to keloid or hypertrophic scar formation.
- Patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.
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 |
|---|---|---|
| Fractional carbon dioxide laserAlso: Ablative fractional laser resurfacingSmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1. | Procedure or surgery | Fractional carbon dioxide laser |
Primary outcome
treatment success
Time frame: One month
reduction of freckles number and color density more than 50% in comparison to pre-treatment digital photos
1 secondary outcome
Treatment safety
Time frame: three months
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 7 Apr 2014.
Related trials for Freckles
Active, not recruitingObservational study
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs
Skin Cancer, Complication
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.
Bakr M Elzawahry, MD study chair
Cairo University
Vanessa G Hafez, MD principal investigator
Cairo University
Aya Fahim, MBBCh principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional carbon dioxide laser in people with Freckles, run by Cairo 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 2 inclusion and 4 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 7 Apr 2014. 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?
treatment success (time frame: One month). 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 7 Apr 2014.