ANTI-DYNAMIC LINE Test for Cream

ChinaNorm

Status: Completed

Conditions: Dynamic Wrinkles

Treatments: Other: Anti-Dynamic Line Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT07067073

C24005075

Details and patient eligibility

About

The goal of this clinical trial is to find out whether a new cream (Formula# 899675 44A) can help reduce dynamic facial and neck wrinkles in young Chinese women. The main questions it aims to answer are:

• Does the cream lower the appearance of forehead wrinkles, crow's feet, under-eye wrinkles, and nasolabial folds when participants smile or raise their eyebrows?
• Does the cream help reduce horizontal neck folds when participants lower their heads?

About 45 healthy women between the ages of 18 and 35 will take part in this 10-week study. They will:

• Stop using other anti-aging products for 2 weeks (wash-out period)
• Apply the study cream on their face and neck twice a day for 8 weeks
• Visit the clinic 4 times for facial and neck photo collection and clinical assessments
• Learn to make standard facial expressions for photo comparisons

Researchers will compare wrinkle changes using dermatologist scores and photo grading at different time points.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Chinese female aged 18-35 years old.

2. All skin types will be contained, including 50% sensitive skin.

3. Regular users of cleanser, anti-aging cream and sunscreen product.

4. Self-claim having concerns of wrinkles problems.

5. Presenting with obvious dynamic wrinkles while making smiling/raising eyebrow expression ( expression reach max condition) evaluated by Dermatologist：

   • Raise eyebrow: Forehead wrinkles (Loreal Atlas, 1<grade≤4)
   • Smile: Underneath eye wrinkles (Loreal Atlas, grade≥3)
   • Smile: Crow's feet wrinkles (Loreal Atlas, grade≥3)
   • Smile: Nasolabial folds (Loreal Atlas, grade>1)

6. Did not participate in any clinical test or cosmetic product test on skin within 3 months.

7. Did not participate any chemical procedures for previous 2 months; and willing to not participate any procedures during the whole study.

8. No disagreement of dermatologist because of other reasons that exclude the participation of the Subject.

9. In general, good health at the time of the study.

10. Willing and able to participate as evidenced by signing of informed consent and photorelease form.

11. Must be willing to comply with all study protocol requirements (pay attention to not take topical or oral treatment like retinol, hormone, antioxidant health-care products which may affect the efficacy of test products).

Exclusion criteria

1. Intending to get pregnant, pregnant, lactating or within 6 months of delivery.
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 (particularly e.g., acne, rosacea, eczema).
7. Subject presenting a stable or progressive serious disease (per investigator's assessment).
8. Immuno-compromised subject.
9. Subject with history of allergy to cosmetic or personal care products or ingredients.
10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
11. Subjects regularly practicing aquatic or nautical sports.
12. Subjects regularly attending a sauna.
13. Subject with cardiovascular or circulatory history.
14. Subject with a history of skin cancer or malignant melanoma.
15. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Investigational Cream Arm

Experimental group

Description:

Participants apply the investigational cream (Formula# 899675 44A) on the entire face and neck twice daily for 8 weeks following a 2-week wash-out period. Application is supervised on-site at baseline and self-administered at home thereafter. Clinical assessments and facial/neck image capture are conducted at baseline, week 4, and week 8.

Treatment:

Other: Anti-Dynamic Line Cream