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The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study

The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study - The verification study for improving skin conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028199
Enrollment
60
Registered
2017-07-12
Start date
2017-07-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese adults

Interventions

Duration: 8 weeks Test materials: Acacia bark extracted tablets Administration: Take 6 tablets in the morning with water or warm water * When you have breakfast, take the tablets after breakfast. I

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Hiroo Dermatology Clinic &amp
Collaborator
Mentors inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese adults who feel discomfort (tickling) with their skin due to drying of their face and/or hands 2. Subjects who are not diagnosed with any skin disease (e.g., atopic dermatitis) and are judged as eligible to participate in the study by the principal investigator. 3. Among the subjects who passed 2., subjects whose TARC level is less than 450 pg/mL and nonspecific IgE level is less than 170 IU/mL 4. Among the subjects who passed 3., subjects whose TEWL is relatively high

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Subjects who are diagnosed with restless legs syndrome 5. Subjects who have been diagnosed with atopic dermatitis 6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare. 7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 8. Subjects who have been overexposed to the sun within the last month before the agreement to participate in this trial, or are going to overexpose to the sun during this trial (from the agreement to participate in this trial to the final test) 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products or who have allergic skins 11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 13. Subjects who are judged as ineligible to participate in the study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
1. Moisture of the skin surface 2. Transepidermal Water Loss (TEWL) *1,2 Assess at 0, 4, and 8 weeks after consuming

Secondary

MeasureTime frame
1. Glossiness of the skin surface 2. Viscoelasticity of the skin 3. Skindex-16 4. The Japanese version of Dermatology Life Quality Index (DLQI) 5. Visual Analogue Scale (VAS) of itching sensation 6. Blood test TARC, nonspecific IgE (RIST) *1-6 Assess at 0, 4, and 8 weeks after consuming

Countries

Japan

Contacts

Public ContactSUZUKI Naoko

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026