Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Extract of Trigonella Foenum-graceum as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123743
Recruitment Status : Active, not recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Shannaz Nadia Yusharyahya, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Skin Aging Drug: Trigonella foenum-graceum extract topical cream Other: Facial Wash Other: Sunscreen Cream Other: Placebo Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.
Primary Purpose: Treatment
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
Actual Study Start Date : August 10, 2019
Estimated Primary Completion Date : November 3, 2019
Estimated Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
Drug: Trigonella foenum-graceum extract topical cream
Topical cream containing Trigonella foenum-graceum extract

Other: Facial Wash
Wardah brand facial wash

Other: Sunscreen Cream
Parasol sunscreen cream SPF 33

Placebo Comparator: Control Group
The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
Other: Facial Wash
Wardah brand facial wash

Other: Sunscreen Cream
Parasol sunscreen cream SPF 33

Other: Placebo
Placebo topical cream




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123743


Locations
Layout table for location information
Indonesia
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Layout table for additonal information
Responsible Party: Shannaz Nadia Yusharyahya, Head of Geriatric Dermatology Division, Department of Dermatovenereology, Faculty of Medicine, Indonesia University, Indonesia University
ClinicalTrials.gov Identifier: NCT04123743     History of Changes
Other Study ID Numbers: 00001
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sunscreening Agents
Phytoestrogens
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists