Clinical efficacy of CICAPLAST BAUME B5+ for symptoms of recovery period after cosmetic procedures

JRCT ID: jRCTs031230421

Registered date:23/10/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Symptoms of recovery period after cosmetic procedures
• Date of first enrollment: 08/11/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

1)After obtaining consent, the Dermapen 4 will be administered at the institution where the procedure is performed.
2)Instrument measurement, evaluation of the observation site, and allocation will be performed at the contract research organization. (Half-sided study on the face)
3)After the allocation, the application of the drug will be evaluated, and the comparator drug will be started and used for 14 days.
4)The contract research organization will perform instrumental measurements and evaluation of the observation site by the physician in charge of evaluation on the day of Dermapen4 application, 2, 3, 5, 7, 14, and 28 days later.

Outcome(s)

• Primary Outcome: Overall clinical evaluation

Secondary Outcome

1) Evaluation of the observed site
Changes over time in erythema, edema/swelling, hemorrhage, crust formation, dryness and desquamation
Presence of PIE and PIH after 28 days
2) Instrumental skin measurements
Changes over time in stratum corneum moisture content, sebum content, and transdermal water transpiration
3) Image analysis by VISIA
Changes over time in erythema and pigmentation
4) Judgment by the Photo Judgment Committee
Overall clinical evaluation, changes over time in erythema, edema/swelling, bleeding, crusting, dryness/debridement
Presence of PIE and PIH after 28 days
5) NRS for pain, NRS for itching
6) questionnaire for Subjects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1)Healthy volunteers between 18 and 65 years old at the time of registration
2)Those who wish to improve facial skin texture, such as acne scars, open pores, fine lines and wrinkles, and loss of elasticity.
3)Those who have no difficulty in filling out questionnaires and other forms
4)Those who can come to the facility to designate observation
5)Those with informed consent for the clinical study

Exclude criteria

1) Those who have skin disease, it is thought that the diseases affect this study.
2) Those who have used medicines (oral or external) and quasi-drugs for whitening and anti-wrinkle, cosmetics containing hydroquinone cosmetics, etc., in the past 1 month.
3) Those using cosmetics or other products containing ingredients with a peeling effect.
4) Those who have undergone cosmetic procedures such as laser, phototherapy, or radiofrequency treatments within 1 month.
5) Those who have undergone surgery, Botox, hyaluronic acid, or other injectable therapy to the face in the past 6 months.
6) Those with a history of contact dermatitis due to cosmetics.
7) Those who may be exposed to excessive ultraviolet radiation during the study.
8) Those who are not suitable for treatment with Dermapen 4.
9) Pregnant or possibly pregnant women, breastfeeding women, or women who wish to become pregnant during study participation.
10) Those who participated in other clinical studies in the past 3 months.
11) Also, subjects that responsible doctors judge that participation in the final examination is inappropriate.

Related Information

• Primary Sponsor: Nogita Toshitatsu
• Secondary Sponsor: Kawashima Makoto
• Source(s) of Monetary Support: NIHON LOREAL K.K.