Evaluation of a cosmetic cream to improve skin tone, barrier function and hydration in adults with long-term insufficient or delayed sleep
| ISRCTN | ISRCTN31286266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31286266 |
| Sponsor | Shenzhen Hujia Technology Co., Ltd |
| Funder | Shenzhen Hujia Technology Co., Ltd |
- Submission date
- 09/10/2026
- Registration date
- 13/10/2026
- Last edited
- 12/10/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rong Hu
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
Building B8, Taohuayuan Science and Technology Innovation Ecological Park, No. 149 Tiegang, Reservoir Road, Xixiang Street, Bao'an District
Shenzhen
518102
China
 ORCID ID |
0009-0009-1239-5795 |
|---|---|
| Phone | +86 (0)755 8656 2982 |
| hurong@hbn.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | Skin effects of a cream containing α-arbutin, ethyl ascorbic acid, and madecassoside in adults with chronic sleep insufficiency and circadian disruption: a two-phase study of acute sleep deprivation challenge and real-world home use |
| Study objectives | The study recruits a single cohort of adults with chronic sleep insufficiency and circadian disruption, drawn from two groups: non-lactating mothers of infants and toddlers, and professional live-stream broadcasters. Participants complete a two-phase study. Phase I is a randomised, evaluator-blinded split-face challenge: one hemiface receives the test cream immediately before a 12-hour supervised acute sleep deprivation (ASD) challenge, and the contralateral hemiface remains untreated; after the challenge, a single application is made to the previously untreated hemiface. Phase II is an open-label period of twice-daily home use of the test cream for 28 days. The main objectives are as follows: 1. To evaluate whether pre-application of the test cream attenuates the deterioration in skin colour and gloss observed on the untreated hemiface during the 12-hour supervised ASD challenge. 2. To quantify the immediate change in skin colour and gloss 5 minutes after a single post-challenge application to the previously untreated hemiface. 3. To evaluate changes in skin barrier function (TEWL), hydration, pigmentation, skin colour, gloss, and participant-reported appearance during 28 days of twice-daily real-world home use. 4. To assess the cutaneous tolerability of the test cream throughout the study. |
| Ethics approval(s) |
Approved 31/10/2025, Intertek China Healthcare & Beauty Products Ethics Committee (4F, No.5 lane 2028, Changzhong Road, Shanghai, 200435, China; +86 (0)21 53397896; bill.zeng@intertek.com), ref: 017 |
| Health condition(s) or problem(s) studied | Adults with chronic sleep insufficiency and circadian disruption |
| Intervention | This is a single-cohort study comprising a randomised, evaluator-blinded split-face challenge followed by an open-label single-arm treatment phase. The study design is classified according to the single-assignment phase because all participants remain in one cohort and the main outcomes come from Phase II. Test product: a cosmetic face cream containing alpha-arbutin, ethyl ascorbic acid and madecassoside. Phase I (split-face challenge): Participants attended the study centre individually between 18:00 and 23:00. After baseline (T0) assessments, performed following standardised facial cleansing and a 30-minute acclimation period, 0.3 ml of the test cream was applied to one randomly assigned hemiface with gentle circular massage until complete absorption; the contralateral hemiface received no product. Participants then remained awake at the centre under continuous supervision for 12 hours. Post-deprivation assessments (T1) were performed the following morning with the cream remaining on the treated hemiface. Immediately after T1, 0.3 ml of the cream was applied to the previously untreated hemiface, and final assessments (T2) were performed 5 minutes later. Phase II (28-day real-world home use): Phase II commenced immediately after Phase I with no washout period; the Phase II baseline (D0) coincided with the Phase I baseline (T0). Participants self-applied the test cream to the entire face twice daily (morning and evening) after routine cleansing for 28 consecutive days. Only habitual facial cleanser, the test cream and habitual sunscreen were permitted; all other functional skincare products and interfering topical medications were prohibited. Participants attended visits at D0, D7 and D28; assessments were performed after standardised cleansing, with no skincare products applied on the day of each visit until all assessments were completed. Randomisation method (within-subject, split-face): The hemiface allocation sequence was prepared in advance by an independent statistician who was not involved in participant recruitment or outcome assessment. According to the pre-generated sequence, one hemiface received the test cream and the contralateral hemiface remained untreated. This within-subject randomisation minimises inter-individual variability and hemiface-related bias when comparing the treated and untreated sides. Blinding: The study was open-label with respect to Phase II. In the Phase I split-face comparison, outcome assessors were blinded to hemiface allocation; participants were aware of which hemiface was treated. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Healthy participants aged 18 to 55 years 2. Chronic sleep insufficiency and circadian disruption for at least the preceding 6 months, defined as habitual late bedtime (sleep onset at or after 00:00 on ≥5 nights per week) and/or insufficient sleep duration (<6 hours per night) 3. Membership of one of two prespecified subgroups: (a) non-lactating mothers of infants and toddlers (children aged ≤2 years) with nocturnal sleep fragmentation attributable to child care; or (b) professional live-stream broadcasters with chronic late bedtime, irregular sleep schedules, or insufficient sleep duration attributable to occupational demands 4. Self-perceived facial dullness or uneven skin tone 5. Screening cheek-site measurements within predefined thresholds: individual typology angle (ITA°) 20°–40°, transepidermal water loss (TEWL) ≥15 g/m²/h, and stratum corneum hydration ≤60 Corneometer units (c.u.) 6. Willingness to maintain habitual sleep patterns throughout the study 7. Completion of structured baseline sleep questionnaires, including the Pittsburgh Sleep Quality Index (PSQI) and the Perceived Stress Scale-10 (PSS-10) 8. Able to understand the trial procedures, take part voluntarily and provide written informed consent |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Systemic medical conditions contraindicating overnight wakefulness, such as uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, insulin-dependent diabetes mellitus, or autoimmune disease 3. Active facial dermatosis, allergic skin disease, known hypersensitivity to cosmetic ingredients, or photosensitivity disorders 4. Use of topical or systemic agents affecting skin colour, barrier function, or inflammation (e.g., retinoids, hydroxy acids, corticosteroids, depigmenting agents) within the previous 4 weeks 5. Facial aesthetic procedures within the previous 3 months, or within 6 months for injectable or energy-based resurfacing procedures 6. Concurrent participation in another interventional clinical trial 7. Any condition judged unsuitable for enrolment by the investigator, including inability to comply with protocol requirements |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 03/12/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Intertek Testing Services Shenzhen Ltd. Guangzhou Branch
Room 301 (Self-compiled), Workshop 2, No. 1 Yuhong Street, Zhongcun Sub-district, Panyu District
Guangzhou
511400
China
Guangzhou
511400
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
09/10/2026: Study’s existence confirmed by the Intertek China Healthcare & Beauty Products Ethics Committee, China.
