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

NCT04123743 | Completed Phase 1

• 1 other identifier: 00001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (4)

• 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)

  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

  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

  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).

  Change from initial visit dermis thickness at 12 weeks

Study Arms (2)

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.

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

Other: Facial Wash; Other: Sunscreen Cream; Other: Placebo

Interventions

Trigonella foenum-graceum extract topical cream DRUG

Topical cream containing Trigonella foenum-graceum extract

Experimental Group

Facial Wash OTHER

Wardah brand facial wash

Control Group; Experimental Group

Sunscreen Cream OTHER

Parasol sunscreen cream SPF 33

Control Group; Experimental Group

Placebo OTHER

Placebo topical cream

Control Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatric Dermatology Division, Department of Dermatovenereology, Faculty of Medicine, Indonesia University

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: August 10, 2019
• Primary Completion: November 3, 2019
• Study Completion: November 10, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

ID (1)