- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07622160
Efficacy Test of a Moisturizing and Anti-aging Facial Mask
Efficacy Test of a Moisturizing and Anti-aging Facial Mask for Skin Improvement
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is a single-center, self-controlled human trial designed to evaluate the skin beauty effect of Moisturizing facial mask and Anti-aging facial mask.
Healthy adult participants aged above 18 years will be enrolled. Participants will be informed to apply the facial mask on whole face three times per week for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after single use, and after continuous use for 2 and 4 weeks.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Pingdong, Taiwan
- Chia Nan University of Pharmacy & Science
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Participants aged 18 years or older
Exclusion Criteria:
- Non-voluntary participants.
- Individuals diagnosed by a physician with skin diseases, liver cirrhosis, or chronic renal failure.
- Individuals with known allergies to cosmetics, medications, or foods.
- Pregnant or breastfeeding individuals.
- Individuals taking medications for chronic diseases.
- Students taught or supervised by the principal investigator.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Hydrating Repairing Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Andre navn:
|
|
Eksperimentell: Anti-aging Rejuvenating Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of skin hydration
Tidsramme: Change from Baseline skin hydration at 4 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 4 weeks
|
|
The change of skin redness
Tidsramme: Change from Baseline skin redness at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin redness.
Units: a* value
|
Change from Baseline skin redness at 4 weeks
|
|
The change of skin texture
Tidsramme: Change from Baseline skin texture at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin texture.
Units: arbitrary units
|
Change from Baseline skin texture at 4 weeks
|
|
The change of skin wrinkles
Tidsramme: Change from Baseline skin wrinkles at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin wrinkles.
Units: arbitrary units
|
Change from Baseline skin wrinkles at 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of transepidermal water loss (TEWL)
Tidsramme: Change from Baseline TEWL at 4 weeks
|
Tewameter® TM300 (CK, Germany) was utilized to measure TEWL.
Units: g/hm²
|
Change from Baseline TEWL at 4 weeks
|
|
The change of skin tone
Tidsramme: Change from Baseline skin tone at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin tone.
Units: Individual Typology Angle (ITA°)
|
Change from Baseline skin tone at 4 weeks
|
|
The change of skin pores
Tidsramme: Change from Baseline skin pores at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin pores.
Units: arbitrary units
|
Change from Baseline skin pores at 4 weeks
|
|
The change of skin elasticity
Tidsramme: Change from Baseline skin elasticity at 4 weeks
|
Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity.
Units: arbitrary units
|
Change from Baseline skin elasticity at 4 weeks
|
|
The change of skin collagen density
Tidsramme: Change from Baseline skin collagen density at 4 weeks
|
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density.
Units: arbitrary units
|
Change from Baseline skin collagen density at 4 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The change of self-assessment skin condition
Tidsramme: Change from Baseline skin condition at 4 weeks
|
Skin condition was evaluated using a 5-point Likert scale (0-4) to assess the severity of skin-related symptoms.
The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Change from Baseline skin condition at 4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Chia-Hua Liang, Ph.D., Chia Nan University of Pharmacy & Science
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TMANH114-REC056
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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