MelasmaNCT03848013
Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
A study testing Q switched Nd YAG laser and Fractional CO2 laser in people with Melasma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
All participants will be divided into 2 groups : Group A \& Group B. Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Melasma
- What is being tested?
- Q switched Nd YAG laser and Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Jun 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- melasma patients above 18 years
Who cannot join
- Pregnancy.
- Usage of chemical peeling 1 month prior to the study.
- Isotretinoin intake 6 months prior to the study.
- Any laser procedure related to melasma lesions 1 month prior to the study.
- Active herpetic lesions.
- Any concurrent active skin disease within the treated area.
Show all 11Show fewer
- Photosensitive skin conditions such as systemic lupus erythematous.
- History of delayed wound healing.
- Keloid formation.
- Bleeding diathesis.
- Medical conditions such as diabetes mellitus \& autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University Kasr Al Ainy Hospital Dermatology department
Cairo, El Manial
About this study
Official title: Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
- All participants will be divided into 2 groups : Group A \& Group B.
- Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions.
- Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
- Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.
- Conditions
- Melasma
- Being tested
- Q switched Nd YAG laser, Fractional CO2 laser
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q switched Nd YAG laserDevice
Laser device emitting Q switched Nd YAG aiming for skin toning
Fractional CO2 laserDevice
Laser device emitting fractionated ablative laser aiming for skin resurfacing
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Treatment of cases of melasma using Q switched Nd YAG laser and Fractional CO2 laser separately and in combination Receives: Device: Q switched Nd YAG laser; Device: Fractional CO2 laser |
| Follow -up period | No intervention | follow up of the treated cases for 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Melasma Area and Severity index change.
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results through measuring modified MASI score before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
Melanin index change.
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results by taking spectrophotometer readings (melanin index) before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
percentage of clinical improvement
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results of masked dermatologists' observation of clinical photographs before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
patient satisfaction rate
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing patient satisfaction before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
Secondary outcomes (4)
Modified Melasma Area and Severity Index change.
Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by measuring changes in modified MASI score before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
Melanin index change.
Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by taking spectrophotometer readings (melanin index) before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
percentage of clinical improvement
Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by comparing the results of masked dermatologists' observation of clinical photographs before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
patient satisfaction rate
Evaluate the role of additional fractional co2 laser to the previously Q switched Nd: YAG treated melasma patients by comparing patient satisfaction before treatment and after treatment and follow-p period.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study startJan 2017
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848013
- Sponsor's protocol ID
- CairoU
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2018
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
- ClinicalTrials.gov ID
- NCT03848013
- Acronym / sponsor ID
- CairoU
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 20 Feb 2019 (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.
- All participants will be divided into 2 groups : Group A \& Group B.
- Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions.
- Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
- Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Q switched Nd YAG laser, Device: Fractional CO2 laserTreatment of cases of melasma using Q switched Nd YAG laser and Fractional CO2 laser separately and in combination |
| Follow -up period | No intervention | –follow up of the treated cases for 2 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- melasma patients above 18 years
Key exclusion criteria (11 listed)
- Pregnancy.
- Usage of chemical peeling 1 month prior to the study.
- Isotretinoin intake 6 months prior to the study.
- Any laser procedure related to melasma lesions 1 month prior to the study.
- Active herpetic lesions.
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 |
|---|---|---|
| Q switched Nd YAG laserLaser device emitting Q switched Nd YAG aiming for skin toning | Device | Treatment |
| Fractional CO2 laserLaser device emitting fractionated ablative laser aiming for skin resurfacing | Device | Treatment |
Primary outcome
Modified Melasma Area and Severity index change.
Time frame: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results through measuring modified MASI score before treatment and after treatment and follow-p period.
Melanin index change.
Time frame: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results by taking spectrophotometer readings (melanin index) before treatment and after treatment and follow-p period.
percentage of clinical improvement
Time frame: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results of masked dermatologists' observation of clinical photographs before treatment and after treatment and follow-p period.
patient satisfaction rate
Time frame: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing patient satisfaction before treatment and after treatment and follow-p period.
4 secondary outcomes
Modified Melasma Area and Severity Index change.
Time frame: 6 months to 1 year
Melanin index change.
Time frame: 6 months to 1 year
percentage of clinical improvement
Time frame: 6 months to 1 year
patient satisfaction rate
Time frame: 6 months to 1 year
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 10 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q switched Nd YAG laser and Fractional CO2 laser in people with Melasma, run by Kasr El Aini Hospital 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 11 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 10 Jan 2020. 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?
Modified Melasma Area and Severity index change. (time frame: 6 months to 1 year). The study lists 4 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 10 Jan 2020.