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Skin enhancement and skin repair efficacy clinical study

Efficacy and tolerability of a facial serum before and after ablative fractional carbon dioxide laser: a randomized controlled trial on Chinese women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60519611
Enrollment
70
Registered
2025-06-30
Start date
2021-12-08
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repair efficacy of skin barrier and condition Skin and Connective Tissue Diseases

Interventions

70 female adults will be enrolled and divided into two groups in the study, recruited according to inclusion and non-inclusion criteria listed below, and at least 60 should complete the whole study (a

Sponsors

L'Oréal Research and Innovation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Chinese women, 20-50 years old 2. All skin types (dry, normal, oily and mixed) 3. No high risk of hyperpigmentation skin (adjusted by the Hyperpigmentation skin questionnaire, refer to Annex 11.2) 4. Rough and dull skin (self-declared) 5. Lack of radiance, brightness, smoothness by self-claimed 6. Presenting with problems of acne marks, acne scars or blemishes on the face 7. Did not participate in any clinical test or cosmetic product test on skin within 3 months 8. Did not participate in any chemical procedures for the previous 2 months and is willing not to participate in any procedures during the whole study 9. No disagreement of the dermatologist because of other reasons that exclude the participation of the volunteer 10. In good general health at the time of the study 11. Willing and able to participate as evidenced by the signing of informed consent 12. Willing and able to participate in the assigned chemical procedure and apply the assigned products 13. Must be willing to comply with all study protocol requirements (pay attention to: only use the skin care products provided during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may affect the anti-ageing efficacy of test serum)

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding woman or woman planning pregnancy during the study 2. Subject deprived of rights by a court or administrative order 3. Major subject to a guardianship order 4. Subject residing in a health or social care establishment 5. Patient in an emergency setting 6. Subject with a skin disease in the test areas as well as skin allergy (particularly, e.g., acne, rosacea, eczema) 7. Volunteer presenting a stable or progressive serious disease (per investigator's assessment) 8. Immuno-compromised subject 9. Subject has hyperpigmentation skin symptoms 10. Subject with a history of allergy to cosmetic or personal care products or ingredients 11. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment) 12. Subjects regularly practising aquatic or nautical sports 13. Subjects regularly attending a sauna 14. Subject with physical highly sensitive constitution 15. Subject with cardiovascular or circulatory history 16. Subject with a history of skin cancer or malignant melanoma 17. Subject with a history of medical beauty treatment and taking part in anti-aging studies in the last 3 months before the study 18. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune suppressants in the last 6 months before study

Design outcomes

Primary

MeasureTime frame
1. Clinical assessment: skin qualities of skin dryness, erythema, papules, desquamation, chromatosis, edema, escharosis, elasticity, evenness, brightness, radiance, smoothness, pores on cheek, crow’s feet wrinkle, epithelial confluence and overall healthy appearance will be evaluated by dermatologist at T0 (baseline), T14d (after pre-treatment), T15d (Timm post-procedure), T16d (1 day after self-recovery), T18d (3 days after self-recovery), T22d (7 days after self-recovery), T25d (10 days after self-recovery and product treatment start), T32d (7 days after product treatment), T39d (14 days after product treatment) for all groups. 2. Sensitivity measured using the lactic acid stinging test at T0 (baseline), T14d (after pre-treatment), T25d (10 days after self-recovery and product treatment start), T39d (14 days after product treatment) for all groups. 3. Skin hydration measured using a corneometer at T0 (baseline), T14d (after pre-treatment), T15d (Timm post-procedure), T16d (1 day after self-recovery), T18d (3 days after self-recovery), T22d (7 days after self-recovery), T25d (10 days after self-recovery and product treatment start), T32d (7 days after product treatment), T39d (14 days after product treatment) for all groups. 4. Transepidermal water loss (TEWL) measured using a vapometer at T0 (baseline), T14d (after pre-treatment), T15d (Timm postprocedure), T16d (1 day after self-recovery), T18d (3 days after self-recovery), T22d (7 days after self-recovery), T25d (10 days after self-recovery and product treatment start), T32d (7 days after product treatment), T39d (14 days after product treatment) for all groups. 5. Skin elasticity (R2, R5, R7) measured using a cutometer at T0 (baseline), T14d (after pre-treatment), T15d (Timm post-procedure), T16d (1 day after self-recovery), T18d (3 days after self-recovery), T22d (7 days after self-recovery), T25d (10 days after self-recovery and product treatment start), T32d (7 days after product treatment), T39d (14 days af

Secondary

MeasureTime frame
1. Product efficacy assessed using self-assessment questionnaire at T14d (after pre-treatment), T25d (10 days after self-recovery), T32d (7 days after product treatment), T39d (14 days after product treatment) for Group 1 (n = 30) 2. Cosmeticity assessed using self-assessment questionnaire at T14d (after pre-treatment), T39d (after product treatment) for Group 1 (n = 30) 3. Post-procedure tolerance assessed using self-assessment questionnaire at T15d (Timm post-procedure), T16d (1 day after self-recovery), T18d (3 days after self-recovery), T22d (7 days after self-recovery), T25d (10 days after self-recovery) for all groups (n = 60)

Countries

China

Contacts

Public ContactXingzuo;Amy Liu;Li

;

xingzuo.liu@loreal.com;amy.li@loreal.com+86 (0)21 5200 8999;+86 (0)21 5200 8999

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026