Clinical evaluation of cosmetic ingredients for whitening and freckle-removing efficacy using a UV-induced pigmentation model
| ISRCTN | ISRCTN11405020 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11405020 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2025GX021FA01 |
| Sponsor | Shenzhen Hujia Technology Co., Ltd. |
| Funder | Shenzhen Hujia Technology Co., Ltd. |
- Submission date
- 29/10/2025
- Registration date
- 30/10/2025
- Last edited
- 30/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
This study is looking at how well 17 common cosmetic ingredients work to lighten dark spots on the skin. These ingredients are often used in products that claim to whiten skin or remove freckles. The goal is to find out which ones are most effective at reducing skin pigmentation.
Who can participate?
Healthy men and women aged 18 to 60 can take part, as long as they have fair, even skin and no history of skin conditions like eczema or psoriasis, or any known allergies.
What does the study involve? (for participants)
If you join the study, small areas of skin on your back will be darkened using UV light to create spots similar to sun damage. You’ll then apply one of the test products (or a placebo) to these areas twice a day for four weeks. Researchers will check how much lighter the skin becomes using a special device and by having a dermatologist look at it.
What are the possible benefits and risks of participating?
By taking part, you’ll be helping researchers learn which ingredients are most effective for skin whitening and freckle removal. This could lead to better cosmetic products in the future. Risks are expected to be low, but there may be some temporary skin irritation or sensitivity from the UV light or the products used.
Where is the study run from?
Shenzhen Hujia Technology Co., Ltd. (China)
When is the study starting and how long is it expected to run for?
August 2025 to December 2025.
Who is funding the study?
Shenzhen Hujia Technology Co., Ltd. (China)
Who is the main contact?
Guoying Li, caohejingschc@163.com
Contact information
Public, Scientific, Principal investigator
Floor 18, Fenglin International Center, Building A
380 Fenglin Road, Xuhui District
Shanghai
200032
China
 ORCID ID |
0009-0002-0313-2706 |
|---|---|
| Phone | +86 17321318135 |
| caohejingschc@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized double-blind controlled interventional cosmetic efficacy trial |
| Secondary study design | Randomised parallel trial |
| Participant information sheet | 48304 PIS ICF-V2.0-2025.8.25 (1).pdf |
| Scientific title | Randomised, double-blind, controlled clinical trial to evaluate the efficacy of 17 common whitening cosmetic ingredients at their maximum permitted concentrations |
| Study objectives | The primary objective is to evaluate and compare the whitening efficacy of 17 cosmetic ingredients in a UV-induced pigmentation model, while secondary objectives include providing data for ingredient selection, revealing efficacy differences, and monitoring adverse events. |
| Ethics approval(s) |
Approved 20/08/2025, Shanghai Ethics Committee For Clinical Research (Floor 18, Fenglin International Center, Building A, Shanghai, 200032, China; +86 17321318135; congyi.song@scrcnet.org), ref: SECCR2025-192-01 |
| Health condition(s) or problem(s) studied | Hyperpigmentation, skin whitening efficacy |
| Intervention | Intervention type: Topical application of cosmetic whitening emulsions Intervention details: 17 whitening cosmetic emulsions tested: Kojic acid (0.7%), Arbutin (2%), Niacinamide (3%), Vitamin C (7%), Tranexamic acid (3%), Resveratrol (1%), Ferulic acid (0.5%), Glabridin (0.15%), Vitamin C Glucoside (5%), Raspberry Ketone Glucoside (2%), Phenylethyl Resorcinol (0.5%), Vitamin E (1%), Hydroxytyrosol (1%), Methoxy Water-Soluble Ferulic Acid Potassium (0.5%), Cinnamon Acid (0.5%), Cinnamic Acid Derivative (3%) Application method: Each emulsion applied twice daily for 4 weeks Application quantity: 2.00±0.05 mg/cm² per test site Area of application: 7.5 cm² per test site Total application amount: 15±0.3 mg per test site Comparator(s): Positive control: 7% Ascorbic Acid (Vitamin C) emulsion Negative control: Base emulsion (placebo vehicle) Blank control: Untreated pigmentation site Randomisation will be conducted by an independent statistician using an online statistical tool (StatBox: Online Statistical Computing System, Xue Yuqiang & Chen Fangyao. Available at: http://www.cnstat.org/statbox/). The statistician will generate the randomisation schedule to determine the allocation of test samples, positive control, negative control, and blank control at each pigmentation site. The randomisation list will be sealed in an envelope, and no allocation information will be disclosed to the investigators, outcome assessors, or data analysts. Both the assessors and data analysts will remain blinded throughout the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. ITA° value (skin color measurement by spectrophotometer) at Day 8 (baseline after pigmentation), Day 15, Day 22, Day 29, and Day 36 |
| Key secondary outcome measure(s) |
Monitoring and reporting of adverse events such as redness, itching, irritation, or allergic reactions related to the intervention measured using patient records throughout with a summary at Day 36 |
| Completion date | 06/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 33 |
| Key inclusion criteria | 1. Healthy male or female participants aged 18 to 60 years 2. Skin ITA° value between 20° and 41° 3. No history of allergic reactions to cosmetics or other topical products 4. No history of photosensitivity disorders or related conditions 5. No pigmentation, scars, or moles at the test site on the back 6. Able to understand the study protocol and provide written informed 7consent to participate in the study |
| Key exclusion criteria | 1. Pregnant or breastfeeding women, or those planning pregnancy 2. History of skin diseases such as psoriasis, eczema, atopic dermatitis, or severe acne 3. Recent use (within 1 month) of corticosteroids or skin-lightening products (e.g., hydroquinone) 4. Participation in another clinical trial within the last 2 months 5. Family history of skin cancer or immunosuppression (e.g., HIV positive, organ transplant recipients) 6. Recent (within 8 weeks) exposure to tanning or excessive sun exposure 7. Participants with a history of allergic reactions to cosmetics or other topical products 8. Participants with pigmentation, inflammation, scars, or moles at the test site 9. Inability to comply with study procedures or unwillingness to sign informed consent |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 15/11/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou
510000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The individual participant data (IPD) will be stored securely and only accessible to authorized personnel within the research team. The anonymized IPD may be shared with other researchers or institutions for further scientific analysis, subject to ethical review and approval. Data will not be shared with external parties without prior approval from the sponsor and ethical committee. IPD will be available upon reasonable request for the purpose of advancing scientific knowledge and improving cosmetic products. Any data shared will adhere to strict confidentiality agreements and data protection laws, ensuring that participant identities remain anonymous. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 25/08/2025 | 30/10/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | in Chinese version 2.0 |
26/08/2025 | 30/10/2025 | No | No |
Additional files
- 48304 Study Protocol-V2.0-20250826.pdf
- in Chinese
- 48304 PIS ICF-V2.0-2025.8.25 (1).pdf
- Participant information sheet
Editorial Notes
29/10/2025: Trial's existence confirmed by Shanghai Ethics Committee For Clinical Research.
