Safety evaluation of cosmetic use at aesthetic medical treatment site for the enlarged facial pores

UMIN ID: UMIN000054557

Registered date:07/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Enlarged facial pore
• Date of first enrollment: 2024/06/09
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Microneedle radiofrequency and formulation containing active ingredient of quasi-drug treatment group
Microneedle radiofrequency and placebo treatment group

Outcome(s)

• Primary Outcome: 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 Outcome: 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 by dermatologist 2. Photographic evaluation by dermatologist 3. Subject questionnaires 4. Instrument evaluation (Corneometer, Tewameter, Cutometer, and Sebumeter)

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 49years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: POLA Chemical Industries, Inc.
• Secondary Sponsor: ALOOP CLINIC&LAB
• Source(s) of Monetary Support: POLA Chemical Industries Inc.