Skin AgingPhase 1/2NCT04123743
Efficacy of Extract of Trigonella Foenum-graceum as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women
A Phase 1/2 study testing Trigonella foenum-graceum extract topical cream, Facial Wash and Sunscreen Cream in people with Skin Aging, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Trigonella foenum-graceum extract topical cream, Facial Wash and Sunscreen Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Aug 2019to 10 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Vein thrombosis
- History of hormonal contraception allergy
- History of ovariectomy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Efficacy of Extract of Trigonella Foenum-graceum (Fenugreek) as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women : A Study of COL1A1, COL3A1, Skin Thickness, and Skin Wrinkles
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.
Read the 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.
- Conditions
- Skin Aging
- Being tested
- Trigonella foenum-graceum extract topical cream, Facial Wash, Sunscreen Cream, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigonella foenum-graceum extract topical creamDrug
Topical cream containing Trigonella foenum-graceum extract
Facial WashOther
Wardah brand facial wash
Sunscreen CreamOther
Parasol sunscreen cream SPF 33
PlaceboOther
Placebo topical cream
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33. Receives: Drug: Trigonella foenum-graceum extract topical cream; Other: Facial Wash; Other: Sunscreen Cream |
| Control Group | Placebo comparator | The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33 Receives: Other: Facial Wash; Other: Sunscreen Cream; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for Forehead Wrinkles
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)
Measured: Change from initial visit VAS at 12 weeks
Visual Analogue Scale for Crow's Feet Wrinkles
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
Measured: Change from initial visit VAS at 12 weeks
Visual Analogue Scale for Nasolabial Wrinkles
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
Measured: Change from initial visit VAS at 12 weeks
High Resolution Ultrasound
High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter).
Measured: Change from initial visit dermis thickness at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start10 Aug 2019
- Primary completion3 Nov 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannaz Nadia Yusharyahya, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123743
- Sponsor's protocol ID
- 00001
- Status last verified
- Jul 2020
- First submitted
- 9 Oct 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extract of Trigonella Foenum-graceum (Fenugreek) as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women : A Study of COL1A1, COL3A1, Skin Thickness, and Skin Wrinkles
- ClinicalTrials.gov ID
- NCT04123743
- Acronym / sponsor ID
- 00001
- Conditions
- Skin Aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Trigonella foenum-graceum extract topical cream, Other: Facial Wash, Other: Sunscreen CreamThe experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33. |
| Control Group | Placebo comparator | Other: Facial Wash, Other: Sunscreen Cream, Other: PlaceboThe control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigonella foenum-graceum extract topical creamTopical cream containing Trigonella foenum-graceum extract | Drug | Experimental Group |
| Facial WashWardah brand facial wash | Other | Control Group, Experimental Group |
| Sunscreen CreamParasol sunscreen cream SPF 33 | Other | Control Group, Experimental Group |
| PlaceboPlacebo topical cream | Other | Control Group |
Primary outcome
Visual Analogue Scale for Forehead Wrinkles
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from initial visit dermis thickness at 12 weeks
High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trigonella foenum-graceum extract topical cream, Facial Wash and Sunscreen Cream in people with Skin Aging, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Forehead Wrinkles (time frame: Change from initial visit VAS at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.