Test Serum Clinical Study

NCT07200635 | Completed

• 1 other identifier: C25005046
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Redness

Outcome Measures

Primary Outcomes (6)

• Skin Hydration Level via Corneometer CM825

  Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .

• Skin Barrier Function via Vapometer® (TEWL Measurement)

  Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .

• Skin Elasticity via Cutometer® Dual MPA 580

  Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .

• Facial Skin Redness and Wrinkle Mapping via VISIA-7 Imaging

  Images are captured at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Da

• 3D Topographical Analysis of Wrinkles and Pores via Antera 3D

  Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .

• Subjective Skin Tolerance and Sensation via Self-Assessment Questionnaire

  Questionnaires are administered at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) ,

Study Arms (3)

Serum Application Regimen

OTHER

Other: Facial serum application

Combination Regimen

OTHER

Other: HA injection; Other: Facial serum application

Injection-Exclusive Regimen

OTHER

Other: HA injection

Interventions

HA injection OTHER

Using vacuum negative pressure technology, hyaluronic acid and other moisturizing nutrients are directly injected into the deep skin, effectively improving dermal dehydration and dryness from the muscle base, so that the skin can quickly replenish water.

Combination Regimen; Injection-Exclusive Regimen

Facial serum application OTHER

Dosage on face: About 0.5g/face for serum.

Combination Regimen; Serum Application Regimen

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese female with 25-40 years old.
• All skin types by subjects' self-perceived.
• Willing to perform HA injection.
• Did not perform any of the beauty procedure projects in the past 6 months.
• Lack of hydration, radiance, brightness, smoothness, firmness and elasticity by self-claimed.
• 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.
• All accept not to use any cosmetics, skincare products, beauty equipment, all topical medications and cleansing products on face at visit days.
• Did not participate any clinical test or cosmetic product test on skin within 1 months.
• No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer.
• In general, good health at the time of the study.

You may not qualify if:

• Pregnant or breast-feeding woman or woman planning pregnancy during the study.
• Subject deprived of rights by a court or administrative order.
• Major subject to a guardianship order.
• Subject residing in a health or social care establishment.
• Patient in an emergency setting.
• Subject with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema).
• Subject presenting a stable or progressive serious disease (per investigator's assessment).
• Immuno-compromised subject.
• Subject with history of allergy to cosmetic or personal care products or ingredients.
• Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
• Subject with history of sunlight sensitivity or allergies.
• Subject regularly practicing aquatic or nautical sports.
• Subject regularly attending a sauna.
• Subject with physical highly sensitive constitution.
• Subject with cardiovascular or circulatory history.

Sponsors & Collaborators

• ChinaNorm: lead

Study Sites (1)

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 1, 2025
• Study Start: June 23, 2025
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)