Enlarged facial pore
Conditions
Interventions
Microneedle radiofrequency and formulation containing active ingredient of quasi-drug treatment group
Microneedle radiofrequency and placebo 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.Healthy Japanese female between the ages of 30 to 49 with enlarged facial pores on their cheeks. 3.Persons who can fill out the consent form and other documents. 4.Persons who can come to the designated facility on the day of the measurement. 5.Persons who can be administered local anesthesia (e.g., lidocaine) 6.Persons who can bring their own cosmetics of facial wash and makeup on the day of the measurement. 7.Persons who can consent to the use of their portraits in media such as product brochures, scientific articles, and distribution of research results in the Web.
Exclusion criteria
Exclusion criteria: 1.Persons who have experienced adverse events such as rash, redness, etc. caused by the ingredients of the test preparation. 2.Persons who have skin conditions such as trauma, acne, eczema, etc. on the cheeks that may affect the examination. 3.Persons who have difficulty enduring the pain caused by needles due to reasons such as difficulty with local anesthesia, or those with aichmophobia. 4.Persons who have a history of surgery or injections (filler, metal, etc.) in the cheeks or those who have received injections such as Botox in the cheeks. 5.Persons who have undergone aesthetic surgery in the past and are currently in the downtime period. 6.Persons who have experienced severe pain, erythema, or scarring as a result of aesthetic surgery. 7.Persons with atopic dermatitis. 8.Persons with allergies to disinfectant alcohol, rubber, metal, or leather products. 9.Persons who taking medicine that may affect the aesthetic surgery treatment (antiplatelet drugs (aspirin, etc.), anticoagulants, etc.), persons who have hemostatic dysfunction, or those who are prone to internal bleeding. 10.Persons who are pregnant, lactating, or planning to become pregnant during the study period. 11.Persons who drink alcohol excessively on a regular basis 12.Persons who are likely to be exposed to significant sunlight exposure or persons who have been or will be attending tanning salons during the period of participation. 13.Persons with a history of liver damage, kidney disease, heart disease, anemia (*persons who have been to the hospital multiple times in the past due to anemia), epilepsy or using a pacemaker, diabetes, or receiving hormone replacement therapy. 14.Persons who are currently participating in another clinical study or will participate in another clinical study during the study period. 15.Persons with fever (*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk) 16.Other persons deemed inappropriate by the research physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation for formulation containing active ingredient of quasi-drug after microneedle radiofrequency treatment for enlarged pores: Compare the adverse events in the group using formulation containing active ingredient of quasi-drug with those in the group using placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation of formulation containing quasi-drug active ingredient for improvement of enlarged facial pores. For the following parameters, the initial values will be compared to the values after treatment of the group using formulation containing active ingredient and the group using placebo. In addition, comparisons between values of these two groups will be made. 1. Visual evaluation 2. Photographic evaluation 3. Subject questionnaires 4. Instrument evaluation | — |
Countries
Japan
Contacts
Public ContactKeitaro Okada
POLA Chemical Industries,Inc. Frontier Research Center
Outcome results
None listed