Skin Aging
Conditions
Brief summary
Skin is subjected to intrinsic aging and extrinsic aging. Intrinsic aging is influenced by genetic and hormonal factors. Estrogen has significant role in modulating skin physiology. In post menopausal women, skin aging is accelerated because of hypoestrogenism. Administration of estrogen can delay the process of skin aging. Phytoestrogens are estrogen-like compounds which can be found naturally in plants. The investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women.
Detailed description
In this double-blinded unmatched randomized controlled trial, the investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women. The investigators have gathered 21 participants that will be divided into 2 groups, experimental group and control group. Experimental group will get treatment with topical cream containing Trigonella foenum-graceum extract, while control group will get treatment with placebo cream. The study will be held in esthetic cluster, Kencana Cipto Mangunkusumo Hospital, and radiology cluster, Kencana Cipto Mangunkusumo Hospital from August 2019 until November 2019.
Interventions
DRUGTrigonella foenum-graceum extract topical cream
Topical cream containing Trigonella foenum-graceum extract
OTHERFacial Wash
Wardah brand facial wash
OTHERSunscreen Cream
Parasol sunscreen cream SPF 33
OTHERPlacebo
Placebo topical cream
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.
Intervention model description
The participants will be divided into 2 groups, experimental group and control group. Experimental group will get intervention with topical cream containing Trigonella foenum-graceum extract, while control group will get intervention with placebo topical cream. Both experimental and control group will receive Wardah brand facial wash and Parasol sunscreen SPF 33 as part of the assigned intervention as well.The participants will undergo the assigned intervention for 12 weeks.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women with minimum 2 years post menopausal and maximum 8 years post menopausal * Have skin aging problems that manifested as wrinkles on forehead, crow's feet, and nasolabial fold region * Estradiol level \< 30 pg/mL * Willing to terminate the routine use of facial cream or treatment during the study duration and at least for 30 days before the study commence * Willing to follow the study protocol and sign the informed consent
Exclusion criteria
* Dermatitis in the region of face * Using oral/topical hormonal supplement in the last 12 months * Using products containing retinoic acid or it's derivatives in the last 30 days * Underwent radiotherapy, facelift, dermabrasion, botox, or facial filler procedures in the last 5 years * Breast lump or other breast abnormality * History of cancer or malignancy * Vein thrombosis * History of hormonal contraception allergy * History of ovariectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for Forehead Wrinkles | Change from initial visit VAS at 12 weeks | Visual Analogue Scale (VAS) to measure wrinkles in the forehead region (Scale 0-8, with 0-2 categorized as mild wrinkling, 3-5 categorized as moderate wrinkling, and 6-8 categorized as severe wrinkling) |
| Visual Analogue Scale for Crow's Feet Wrinkles | Change from initial visit VAS at 12 weeks | Visual Analogue Scale (VAS) to measure wrinkles in crow's feet region (Scale 0-6), with 0-2 categorized as mild wrinkling, 3-4 categorized as moderate wrinkling, and 5-6 categorized as severe wrinkling |
| Visual Analogue Scale for Nasolabial Wrinkles | Change from initial visit VAS at 12 weeks | Visual Analogue Scale (VAS) to measure wrinkles in nasolabial region (Scale 0-6), with 0-2 categorized as mild wrinkling, 3-4 categorized as moderate wrinkling, and 5-6 categorized as severe wrinkling |
| High Resolution Ultrasound | Change from initial visit dermis thickness at 12 weeks | High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter). |
Countries
Indonesia
Outcome results
None listed