CompletedNot Applicable

12-Week Efficacy Clinical Study of Serum

China73 participantsStarted 2023-08-02

Plain-language summary

65 female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 40 subjects should complete the clinical evaluation and 60 subjects should complete consumer questionnaire in this 15-week study (wash-out phase for 3 weeks and treatment phase for 12 weeks). Subjects will need to refrain from using any product other than the provided test products on whole face including eye area during the 3-week wash-out phase and 12-week study treatment phase.

Who can participate

Age range25 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Chinese women aged from 25-55 years old.
✓. All skin types, including 50% sensitive skin.
✓. Regular users of serum with anti-aging need.
✓. Self-claim concerns of skin quality problem (radiance, smoothness, pore) and aging problems (fine lines, wrinkles, elasticity).
✓. Presenting with corresponding severity for the attribute evaluated by Dermatologist： Crows' feet wrinkle (Loreal atlas, 2≤grade≤5) Underneath Eye Wrinkle (Loreal atlas, 2≤grade≤5) Inter Ocular Wrinkles (Loreal atlas, 1\<grade≤4) Glabellar wrinkles (Loreal atlas, 1\<grade≤4) Nasolabial fold (Loreal atlas, 2≤grade≤4) Forehead wrinkle (Loreal atlas, 2≤grade≤5) Fine lines on the forehead (Loreal atlas, 1\<grade≤4) Cheek folds (Loreal atlas, 2≤grade≤5) Wrinkles of the corner of the lips (Loreal atlas, 1\<grade≤4)
✓. Clinical grading of skin pores, skin radiance and skin smoothness: 4≤grade≤6 evaluated by dermatologist.
✓. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
✓. In general good health at the time of the study.

Exclusion criteria

✕. 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.

What they're measuring

Time effect of skin smoothness (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin radiance (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin pore (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin elasticity (Tactile)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin firmness (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of forehead wrinkles

Timeframe: Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Trial details

NCT IDNCT06968416

SponsorChinaNorm

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-17

View on ClinicalTrials.gov More Anti-aging trials

Plain-language summary

Who can participate

Age range25 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Chinese women aged from 25-55 years old.
✓. All skin types, including 50% sensitive skin.
✓. Regular users of serum with anti-aging need.
✓. Self-claim concerns of skin quality problem (radiance, smoothness, pore) and aging problems (fine lines, wrinkles, elasticity).
✓. Presenting with corresponding severity for the attribute evaluated by Dermatologist： Crows' feet wrinkle (Loreal atlas, 2≤grade≤5) Underneath Eye Wrinkle (Loreal atlas, 2≤grade≤5) Inter Ocular Wrinkles (Loreal atlas, 1\<grade≤4) Glabellar wrinkles (Loreal atlas, 1\<grade≤4) Nasolabial fold (Loreal atlas, 2≤grade≤4) Forehead wrinkle (Loreal atlas, 2≤grade≤5) Fine lines on the forehead (Loreal atlas, 1\<grade≤4) Cheek folds (Loreal atlas, 2≤grade≤5) Wrinkles of the corner of the lips (Loreal atlas, 1\<grade≤4)
✓. Clinical grading of skin pores, skin radiance and skin smoothness: 4≤grade≤6 evaluated by dermatologist.
✓. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
✓. In general good health at the time of the study.

Exclusion criteria

✕. 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.

What they're measuring

Time effect of skin smoothness (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin radiance (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin pore (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin elasticity (Tactile)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of skin firmness (Visual)

Timeframe: Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

Time effect of forehead wrinkles

Timeframe: Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.