MedPath

Cream Short-term Efficacy Clinical Study

Not Applicable
Completed
Conditions
Facial Wrinkles and Rhytides Reduction
Registration Number
NCT07067086
Lead Sponsor
ChinaNorm
Brief Summary

This study aimed to evaluate the short-term efficacy of a facial cream (Formula# 899675 44A) on improving various skin quality and wrinkle parameters after a single application. A total of 44 healthy Chinese women aged 20 to 50 years, with all skin types including 50% sensitive skin, were enrolled. Participants applied the cream once to the full face and neck under supervision, and outcomes were assessed at baseline (T0), 10 hours (T10h), and 24 hours (T24h) post-application. Clinical evaluations and photo-based imaging were used to assess skin plumpness, smoothness, radiance, and multiple types of wrinkles. At the end of the study, 42 participants completed the protocol.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
42
Inclusion Criteria
  • 1.Chinese female with 20-50 years old (Must have 20-30 years old). 2.In general, good health at the time of the study. 3.All skin types, with 50% sensitive skin. 4.Regular users for cleanser, anti-aging cream and sunscreen product. 5.Self-declare with plumpness, smoothness and wrinkles problems. 6.Clinical grading by dermatologist in terms of: Underneath eye wrinkles: 2≤grade≤4; Forehead wrinkles: 1 <grade≤ 4; Crow's feet wrinkles: grade > 1; Skin smoothness: 3≤ grade≤ 6 (0-9 scale); Skin plumpness: 3≤ grade≤ 6 (0-9 scale); 7.Did not participate any clinical test or cosmetic product test on skin within 3 months.

    8.Did not participate any chemical/beauty procedures for previous 6 months. 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.

    10.Were willing and able to participate as evidenced by signing of informed consent and photo release form.

    11.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.Subjects regularly practicing aquatic or nautical sports. 12.Subjects regularly attending a sauna. 13.Subject with physical highly sensitive constitution. 14.Subject with cardiovascular or circulatory history. 15.Subject with a history of skin cancer or malignant melanoma. 16.Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Time effect of cheek plumpness (Visual)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin radiance (Visual)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin smoothness (Visual)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin elasticity (Tactile)Compare to baseline, 10h, 24h
Secondary Outcome Measures
NameTimeMethod
Time effect of forehead wrinkles (Photo analysis)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of global fine lines (Visual)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of crow's feet wrinkles (Photo analysis)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin firmness (Visual)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of nasolabial folds (Photo analysis)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin hydration (Corneometer)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin TEWL (Tewameter)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin glossiness (Glossymeter)Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin redness (Chromameter)Compare to baseline, Time point at 10 hours, Time point at 24 hours.

Trial Locations

Locations (1)

Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072

🇨🇳

Shanghai, China

Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
🇨🇳Shanghai, China

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