Dermatitic Reaction of FaceNCT05245383
Skin Irritation Test of Ten Products
A study testing ten products (S01~S10) and two blank (BK1, BK2) in people with Dermatitic Reaction of Face, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Evaluation of cutaneous tolerance of ten products by primary irritant patch test Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitic Reaction of Face
- What is being tested?
- ten products (S01~S10) and two blank (BK1, BK2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Dec 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 70 years old, healthy male and female (sex ratio 1:1)
- No acute or chronic diseases including skin diseases.
- No current medications.
Who cannot join
- Pregnancy or breast feeding.
- Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
- Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
- Current dermatology medication which might affect skin condition evaluation.
- Current irritated reaction on test site.
- Participating in other clinical trial(s) within 7 days.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
SUNG-JAN LIN, +8862-23123456 ext. 62141, drsjlin@ntu.edu.tw
PO-HUA CHEN, +886-2-23123456 ext. 62141, walile0425@gmail.com
About this study
Evaluation of cutaneous tolerance of ten products by primary irritant patch test
Read the detailed description
The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.
- Conditions
- Dermatitic Reaction of Face
- Being tested
- ten products (S01~S10) and two blank (BK1, BK2)
- Keywords
- skin, skin health, allergen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ten products (S01~S10) and two blank (BK1, BK2)Other
S01 "Functional Peptides Recovering Essence EX" S02 "Advanced Revitalizing Eye Cream" S03 "Advanced Revitalizing Lotion" S04 "NB-1 Anti-Sensitive Repair Activator" S05 "NB-1 Anti-Sensitive Repair Toning Extract" S06 "Ginseng Vitality Serum" S07 "Ginseng Revitalizing Age-defense Essence Cream" S08 "Ginseng Age-defense Eye Cream" S09 "Revital Energy Balance Gel" S10 "Revital Energy Tightening Body Lotion" BK1 "Water" BK2 "Blank" ten products and two blank, 24 hours single application patch test on the back.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Not described Receives: Other: ten products (S01~S10) and two blank (BK1, BK2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Adverse Event Outcome Measure
Number of participants with Serous and Non-Serous Adverse Event
Measured: Up to 48 hours
Total Number of Positive Responses Across All Participants
Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading
Measured: Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start17 Dec 2021
- Primary completion29 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitic Reaction of FaceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SUNG-JAN LIN, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245383
- Sponsor's protocol ID
- 202107020RSD
- Status last verified
- Nov 2021
- First submitted
- 23 Dec 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505.
PubMed 24909212Fullerton A, Benfeldt E, Petersen JR, Jensen SB, Serup J. The calcipotriol dose-irritation relationship: 48 hour occlusive testing in healthy volunteers using Finn Chambers. Br J Dermatol. 1998 Feb;138(2):259-65. doi: 10.1046/j.1365-2133.1998.02071.x.
PubMed 9602871
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Irritation Test of Ten Products
- ClinicalTrials.gov ID
- NCT05245383
- Acronym / sponsor ID
- 202107020RSD
- Conditions
- Dermatitic Reaction of Face
- Keywords
- skin, skin health, allergen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 29 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of cutaneous tolerance of ten products by primary irritant patch test
Detailed description
The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: ten products (S01~S10) and two blank (BK1, BK2) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 70 years old, healthy male and female (sex ratio 1:1)
- No acute or chronic diseases including skin diseases.
- No current medications.
Key exclusion criteria (6 listed)
- Pregnancy or breast feeding.
- Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
- Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
- Current dermatology medication which might affect skin condition evaluation.
- Current irritated reaction on test site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ten products (S01~S10) and two blank (BK1, BK2)S01 "Functional Peptides Recovering Essence EX" S02 "Advanced Revitalizing Eye Cream" S03 "Advanced Revitalizing Lotion" S04 "NB-1 Anti-Sensitive Repair Activator" S05 "NB-1 Anti-Sensitive Repair Toning Extract" S06 "Ginseng Vitality Serum" S07 "Ginseng Revitalizing Age-defense Essence Cream" S08 "Ginseng Age-defense Eye Cream" S09 "Revital Energy Balance Gel" S10 "Revital Energy Tightening Body Lotion" BK1 "Water" BK2 "Blank" ten products and two blank, 24 hours single application patch test on the back. | Other | Single arm |
Primary outcome
Safety/Adverse Event Outcome Measure
Time frame: Up to 48 hours
Number of participants with Serous and Non-Serous Adverse Event
Total Number of Positive Responses Across All Participants
Time frame: Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.
Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 24909212Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505.
- Background: PubMed 9602871Fullerton A, Benfeldt E, Petersen JR, Jensen SB, Serup J. The calcipotriol dose-irritation relationship: 48 hour occlusive testing in healthy volunteers using Finn Chambers. Br J Dermatol. 1998 Feb;138(2):259-65. doi: 10.1046/j.1365-2133.1998.02071.x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SUNG-JAN LIN principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ten products (S01~S10) and two blank (BK1, BK2) in people with Dermatitic Reaction of Face, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Jan Lin (02 - 23123456 ext. 62141, drsjlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Adverse Event Outcome Measure (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.