HyperpigmentationNCT04765930
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
A study testing Q-switched nd:YAG laser toning in people with Hyperpigmentation and Melasma, run by Cairo University at 1 site in Egypt.
Trial summary
Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperpigmentation, Melasma, PRP
- What is being tested?
- Q-switched nd:YAG laser toning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral nearly symmetric melasma on the face.
Who cannot join
- Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
- Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
- Patients active skin infections and active HSV
- History of hypertrophic scars or keloids.
- Patients with hypercoagulable state or bleeding diatheses
- Pregnant and lactating females.
- History of liver diseases
- Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Dermatology, Cairo University
Cairo
Mona El-Kalioby, MD, monaelkalioby@cu.edu.eg
Tahra Leheta, MD
About this study
Official title: Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.
Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.
- Conditions
- Hyperpigmentation, Melasma, PRP, Lasers
- Being tested
- Q-switched nd:YAG laser toning
- Keywords
- laser toning, Hemi-MASI, Colorimeter, Erythema Index, Melanin Index
- Medical subject headings
- Hyperpigmentation, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-switched nd:YAG laser toningOther
Q-switched nd:YAG laser toning for melasma.
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Active comparator | Half of the face Receives: Other: Q-switched nd:YAG laser toning |
| Saline injection | Placebo comparator | Other half of the face Receives: Other: Q-switched nd:YAG laser toning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemi-Melasma Area and Severity Index (MASI) score
Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome.
Measured: 2 months after final treatment
Secondary outcomes (2)
Melanin Index
Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.
Measured: 2 months after final treatment
Erythema Index
Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.
Measured: 2 months after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Oct 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona El-Kalioby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765930
- Sponsor's protocol ID
- MelaPRP2020
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.
- ClinicalTrials.gov ID
- NCT04765930
- Acronym / sponsor ID
- MelaPRP2020
- Conditions
- Hyperpigmentation, Melasma, PRP, Lasers
- Keywords
- laser toning, Hemi-MASI, Colorimeter, Erythema Index, Melanin Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 23 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.
Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Active comparator | Other: Q-switched nd:YAG laser toningHalf of the face |
| Saline injection | Placebo comparator | Other: Q-switched nd:YAG laser toningOther half of the face |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bilateral nearly symmetric melasma on the face.
Key exclusion criteria (8 listed)
- Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
- Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
- Patients active skin infections and active HSV
- History of hypertrophic scars or keloids.
- Patients with hypercoagulable state or bleeding diatheses
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 laser toningQ-switched nd:YAG laser toning for melasma. | Other | PRP Injection, Saline injection |
Primary outcome
Hemi-Melasma Area and Severity Index (MASI) score
Time frame: 2 months after final treatment
Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome.
2 secondary outcomes
Melanin Index
Time frame: 2 months after final treatment
Erythema Index
Time frame: 2 months after final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Yes
Related trials for Hyperpigmentation
RecruitingPhase 4
Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
Telangiectasias, Reticular Veins
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
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.
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 toning in people with Hyperpigmentation and Melasma, 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Feb 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona El-Kalioby, MD (+201224442941, mona.elkalioby@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemi-Melasma Area and Severity Index (MASI) score (time frame: 2 months after final treatment). 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 23 Feb 2021.