An interventional study of Investigational Serum, Standard Cleanser and Infrared Light for Redness Induction on Face in Female and Redness, sponsored by ChinaNorm. Completed at 1 site in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
This study is a mono-centric, om-site use, random half-face application, blank control study. 64 female adult subjects will be enrolled and divided into 2 groups in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 30 subjects for each group should complete the test in this 1 visit study.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 65 is above the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →ChinaNorm is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Investigational Serum, Standard Cleanser · Device: Infrared Light for Redness Induction on Face
Device: Infrared Light for Redness Induction on Face
Mode of Group Serum application : On-site single use Standard cleanser + Investigational Serum (random half-face) \[FLA #2039128 50\] \- subjects should wash face with standard cleanser \[FLA #730457 36\] on site before measurements. The technician will apply the Investigational Serum \[FLA #2039128 50\] on the subject's half face (according to the Annex 11.6) at the test site, keep another half face as blank control.
Infrared light has high radiation frequency, its permeability is strong, the wavelength of infrared light can penetrate the human dermis to promote blood circulation and induce skin redness.The redness induction process will be done after baseline measurements for each subject.The subject's face was exposed at a distance of 20cm from infrared lamp for minimum 5 - 10 minutes at a temperature of 30-40°C and a wavelength of 760-5000 nm. In general, the skin will not be burned during the induction process. Due to individual differences, if the subjects cannot tolerate or feel uncomfortable during the process, the investigators will stop the process according to the situation; If there is any burn during the process, the on-site dermatologist will treat it in time, and the subject needs to follow the dermatologist's advice for follow-up treatment. Infrared light type: PHILIPS, IR250 RH IR2, 230-250V, 250W, wave length 760-5000nm, T 30\~40°C
Clinical scoring for skin redness
Participants: N= 30
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Clinical scoring for skin redness
Participants: N= 30
Time frame: Baseline, Time point post-induction 5 min.
Image Capture and Analysis（Redness area ratio）
Participants: N= 30，by VISIA 7
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Image Capture and Analysis（Redness area ratio）
Participants: N= 30,by TiVi 700 Tissue Viability Imager
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Instrumental Assessment (Erythema index)
Participants: N= 30, by Mexameter
Time frame: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Consumer Questionnaire
Participants: N= 60
Time frame: Time point post-intervention 10 sec, Time point post-intervention 1 min, Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Plan to share: Yes — This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 18-Month Duration: The data sharing period starts upon study completion and PRS registration completion. Timeline: Months 2-3: Data de-identification, metadata preparation, and platform integration. Month 4: Official launch of data access.
Access criteria: Primary Platform: ResMan (www.medresman.org.cn) - China's leading medical research data repository. Eligibility: Researchers/affiliates from academic institutions, hospitals, or registered research organizations. Engaged in dermatology, cosmetic science, or related fields. Able to demonstrate ethical compliance and data security capabilities.
Data sharing details ↗ · www.medresman.org.cn
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Apr 2024, 0 months.
Of 43 interventional studies with no phase under Erythema, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 11. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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