Melasma
Conditions
Brief 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. * 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.
Interventions
DEVICEQ switched Nd YAG laser
Laser device emitting Q switched Nd YAG aiming for skin toning
DEVICEFractional CO2 laser
Laser device emitting fractionated ablative laser aiming for skin resurfacing
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* melasma patients above 18 years
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction rate | 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. |
| Modified Melasma Area and Severity index change. | 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. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Melasma Area and Severity Index change. | 6 months to 1 year | 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. |
| Melanin index change. | 6 months to 1 year | 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. |
| percentage of clinical improvement | 6 months to 1 year | 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. |
| patient satisfaction rate | 6 months to 1 year | 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. |
Countries
Egypt
Outcome results
None listed