Melasma
Conditions
Interventions
Pico Laser Toning and quasi-drug treatment group
Pico Laser Toning treatment group
Sponsors
POLA Chemical Industries, Inc.
ALOOP CLINIC &
LAB
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Persons who have received an explanation of this research, understand the purpose of the research and the risks involved, and agree to participate in the research of their own free will (i.e., persons who have given their informed consent) (2) Persons with melasma (3) Healthy Japanese female ages 40 to 59 years old, who do not meet the exclusion criteria (4) Persons who can fill out the consent form and other documents (5) Persons who can come to the designated facility on the day of the measurement (6) Persons who can bring their own cosmetics of facial wash and makeup on the day of the measurement.
Exclusion criteria
Exclusion criteria: (1) Persons who have skin symptoms such as external wound, acne, and eczema, etc. on the face (2) Persons who have a history of surgery or injections on the face (3) Persons who have undergone cosmetic surgery in the past and are currently in the downtime (4) Persons who have experienced severe pain, erythema, or scarring after undergoing cosmetic surgery in the past (5) Persons who have undergone cosmetic medical surgery (laser irradiation, photo-facial, injection therapy, HIFU, incision, thread lift, etc.) that affect the shape and/or skin color tone of the face (6) Persons with a history of atopic dermatitis (7) Persons with allergies to disinfectant alcohol and/or rubber (8) Persons with a history of cancer of the head and/or neck (9) Persons who are pregnant, lactating, or planning to become pregnant during the study period (10) Persons who drink alcohol excessively on a regular basis (11) Persons who regularly go or plan to go to tanning salons or plan to do so during the study period. (12) Persons who are expected to suffer from severe hay fever* during the study period (*level requiring a hospital visit) (13) Persons who are likely to be exposed to significant sunlight during the study period (e.g., Daily exercise during the daytime) (14) Persons with a history of serious hepatic disorder, renal disorder, or myocardial infarction (15) Persons with severe anemia (* Persons who have been to the hospital multiple times in the past due to anemia) (16) Persons receiving hormone replacement therapy (17) Persons who are currently participating in another clinical study or will participate in another clinical study during the study period (18) Persons with fever (*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk) (19) Persons who have experienced rashes from plants, trees, or hair dye (20) Other persons deemed inappropriate by the research physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation for quasi-drug use after Pico Laser Toning irradiation: The difference in the adverse events in group comparison between the quasi-drug use and non-treated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation for quasi-drug use after Pico Laser Toning irradiation for improvement of melasma. Regarding the following 6 parameters, the changes from the initial value will be evaluated. And, a group comparison between the quasi-drug use and non-treated will be conducted. 1. Assessment of MASI score by dermatologist A dermatologist will evaluate the MASI score of facial melasma. 2. Assessment of IGA grade by dermatologist A dermatologist will evaluate the IGA grade of facial melasma. 3. Self-assessment by participants Participants themselves will evaluate the IGA grade of facial melasma. 4. Facial imaging analyses: Facial imaging analysis will be performed by VISIA and calculated the pigmentation and redness score with the attached software. Additional evaluation 5. Evaluation of facial measurement parameters Skin water contents, Trans epidermal water loss, and Viscoelasticity, sebum secretions will be measured. 6. Self-assessment of skin sensation by participants Participants themselves will evaluate the skin sensation by questionnaires. | — |
Countries
Japan
Contacts
Public ContactFumiya Yamaji
POLA Chemical Industries, Inc. Frontier Research Center
Outcome results
None listed