A randomized, open-label, controlled study of skincare guidance by health care professionals using cosmetics for patients with skin diseases

JRCT ID: jRCT1030220212

Registered date:14/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis, systemic sclerosis, asteatotic eczema, others
• Date of first enrollment: 09/06/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients with skin diseases will be divided into two groups: Group A (skin care instruction at the beginning and 4 weeks after the start of the study) and Group B (skin care instruction 4 weeks after the start of the study), using commercially available skin care products (quasi-drugs and cosmetics).

Outcome(s)

• Primary Outcome: Improved drug application to the face

Secondary Outcome

Changes in the stratum corneum water content, epidermal water transpiration, cytokines
Patient quality of life survey
Amount of topical agents used
Skin age

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria 1)~5)
1) Patients with skin diseases
2) Patients who do not plan to change the drug used to treat the primary disease (no restriction on change in dosage).
3) Be male or female, 20 years of age or older.
4) The subject must be able to practice the skincare instructed at home by him/herself.
5) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

1) Persons who have experienced contact dermatitis or other skin conditions caused by the ingredients contained in this skincare product or similar ingredients in the past.
2) Patients who have skin rashes or other skin conditions inappropriate for the application of this skincare product to the area of application.
3) Patients who cannot be examined after 4 to 8 weeks (in principle).
4) Pregnant or nursing mothers
5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
6) Other patients who are deemed inappropriate as research subjects by the investigator.

Related Information

• Primary Sponsor: Yoshizaki Ayumi
• Secondary Sponsor: Sato Shinichi