RednessNCT07179263
Inducing Redness Clinical Study
A study testing 50% glycolic acid and Tape Stripping in people with Redness, run by ChinaNorm at 1 site in China.
Trial summary
This clinical study employs a single-center, split-face, randomized, and on-site controlled design to compare two methods for inducing skin redness (50% Glycolic Acid application and tape stripping) on the face and forearm in a minimum of 40 healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Redness
- What is being tested?
- 50% glycolic acid and Tape Stripping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2023to 29 Dec 2023
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese female whose age range from 18 to 60 years old;
- Be in general good health and good mental state;
- Have no any broken, scars, birthmarks and other imperfections on the test area;
- Redness/erythema ≥ grade 2 after modelling inducing (to ensure the consistency of the baseline for comparison);
- Haven't applied Alpha hydroxyl acid in the past 3 months;
- Not currently be participating in any other study involving the test area (Face and Forearm);
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- Not have participated in any other study involving the test area in the past one month;
- Be willing to read, understand and able to sign the Informed Consent Form and Photo Release From;
- Be willing to comply with all study protocol requirements.
Who cannot join
- Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
- Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
- Take anti-allergic drug/injections in the past 1 month;
- Presently have allergies, allergic dermatitis or skin disease;
- Have sensitivity or even allergy to topical products, ingredients or fragranced products;
- Have history of allergies;
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- Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
- Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
- Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
- Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
- Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;
- Have excessive sun exposure or ultraviolet light in the past 1 month;
- Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives (such as Diane 35®，Jasmine®， Holgyeme®，Syndi 35®，Regulon®);
- Avoid providing emergency contact;
- Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
- An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
About this study
This clinical study employs a single-center, split-face, randomized, and on-site controlled design to compare two methods for inducing skin redness (50% Glycolic Acid application and tape stripping) on the face and forearm in a minimum of 40 healthy female subjects. The study involves instrumental measurements (erythema index and a* value), photographic analysis, and expert clinical grading at multiple time points (baseline, 10min, 30min, 1h, 2h, and 4h after induction) to evaluate and compare the efficacy and response profiles of both irritation models.
- Conditions
- Redness
- Being tested
- 50% glycolic acid, Tape Stripping
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% glycolic acidOther
Subjects use 3 drops about 0.2g of 50% Glycolic Acid product on half face under instruction, then wait for 3 minutes and wash face by tap water. Wait for 10 minutes before measuring.
Tape StrippingOther
Technician use the D100 to paste on the center of the test area and make it fit the skin more completely and evenly by pump fully cover the D100 patch for 10 seconds. Stripping on each test area until the skin change into redness. The number of stripping will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Facial Test Arm | Other | Not described Receives: Other: 50% glycolic acid; Other: Tape Stripping |
| Facial Control Arm | No intervention | Not described |
| Arm Test arm | Other | Not described Receives: Other: Tape Stripping |
| Arm control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythema index by Mexameter® MX 18 (
Measured: From baseline to 4-hour after inducing
Change in a* value by Chromameter CM26dG
The a*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .
Measured: From baseline to 4-hour after inducing
Facial Erythema Severity via VISIA-CRP Imaging
Measured: From baseline to 4-hour after inducing
Forearm Erythema Intensity via Cross-Polarized Light Imaging
Measured: From baseline to 4-hour inducing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start22 Dec 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RednessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179263
- Sponsor's protocol ID
- C23036014
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducing Redness Clinical Study
- ClinicalTrials.gov ID
- NCT07179263
- Acronym / sponsor ID
- C23036014
- Conditions
- Redness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 17 Sep 2025 (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.
This clinical study employs a single-center, split-face, randomized, and on-site controlled design to compare two methods for inducing skin redness (50% Glycolic Acid application and tape stripping) on the face and forearm in a minimum of 40 healthy female subjects. The study involves instrumental measurements (erythema index and a* value), photographic analysis, and expert clinical grading at multiple time points (baseline, 10min, 30min, 1h, 2h, and 4h after induction) to evaluate and compare the efficacy and response profiles of both irritation models.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facial Test Arm | Other | Other: 50% glycolic acid, Other: Tape Stripping |
| Facial Control Arm | No intervention | – |
| Arm Test arm | Other | Other: Tape Stripping |
| Arm control arm | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Chinese female whose age range from 18 to 60 years old;
- Be in general good health and good mental state;
- Have no any broken, scars, birthmarks and other imperfections on the test area;
- Redness/erythema ≥ grade 2 after modelling inducing (to ensure the consistency of the baseline for comparison);
- Haven't applied Alpha hydroxyl acid in the past 3 months;
Key exclusion criteria (16 listed)
- Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
- Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
- Take anti-allergic drug/injections in the past 1 month;
- Presently have allergies, allergic dermatitis or skin disease;
- Have sensitivity or even allergy to topical products, ingredients or fragranced products;
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 |
|---|---|---|
| 50% glycolic acidSubjects use 3 drops about 0.2g of 50% Glycolic Acid product on half face under instruction, then wait for 3 minutes and wash face by tap water. Wait for 10 minutes before measuring. | Other | Facial Test Arm |
| Tape StrippingTechnician use the D100 to paste on the center of the test area and make it fit the skin more completely and evenly by pump fully cover the D100 patch for 10 seconds. Stripping on each test area until the skin change into redness. The number of stripping will be recorded. | Other | Arm Test arm, Facial Test Arm |
Primary outcome
Change in erythema index by Mexameter® MX 18 (
Time frame: From baseline to 4-hour after inducing
Change in a* value by Chromameter CM26dG
Time frame: From baseline to 4-hour after inducing
The a*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .
Facial Erythema Severity via VISIA-CRP Imaging
Time frame: From baseline to 4-hour after inducing
Forearm Erythema Intensity via Cross-Polarized Light Imaging
Time frame: From baseline to 4-hour inducing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% glycolic acid and Tape Stripping in people with Redness, run by ChinaNorm at 1 site in China.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 17 Sep 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erythema index by Mexameter® MX 18 ( (time frame: From baseline to 4-hour after inducing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.