Test Serum Clinical Study

ChinaNorm

Status: Completed

Conditions: Redness

Treatments: Other: HA injection; Other: Facial serum application

Study type: Interventional

Funder types: Industry

Identifiers

NCT07200635

C25005046

Details and patient eligibility

About

This 4-week, mono-centric clinical study employed a randomized three-arm design to evaluate the efficacy of a test serum. The study compared three interventions: the test serum used alone, the test serum used in combination with hyaluronic acid (HA) injection, and HA injection alone. It aimed to assess their effects on skin quality and wrinkles in 90 healthy Chinese female subjects aged 25-40. Evaluations were conducted at multiple timepoints through clinical assessments, instrumental measurements, and image analysis.

Enrollment: 90 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Chinese female with 25-40 years old.

2. All skin types by subjects' self-perceived.

3. Willing to perform HA injection.

4. Did not perform any of the beauty procedure projects in the past 6 months.

5. Lack of hydration, radiance, brightness, smoothness, firmness and elasticity by self-claimed.

6. Presenting with corresponding severity for the attribute evaluated by Dermatologist included:

   • Radiance, smoothness, elasticity, cheek plumpness and firmness: 3≤grade≤6.
   • Global fine lines: 3≤grade.
   • Underneath eye wrinkles: 2≤grade≤5.
   • Forehead wrinkles: 1<grade≤4.
   • Glabella wrinkles: 1<grade.

7. All accept not to use any cosmetics, skincare products, beauty equipment, all topical medications and cleansing products on face at visit days.

8. Did not participate any clinical test or cosmetic product test on skin within 1 months.

9. No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer.

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

11. Willing and able to participate as evidenced by signing of informed consent & photo release form.

12. Must be willing to comply with all study protocol requirements.

Exclusion criteria

1. Pregnant or breast-feeding 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. 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. Subject with history of sunlight sensitivity or allergies.
12. Subject regularly practicing aquatic or nautical sports.
13. Subject 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. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Serum Application Regimen

Other group

Treatment:

Other: Facial serum application

Combination Regimen

Other group

Treatment:

Other: Facial serum application

Other: HA injection

Injection-Exclusive Regimen

Other group

Treatment:

Other: HA injection