NCT06146140

Brief Summary

The purpose of this study is to evaluate how an oral herbal supplementation influences facial skin elasticity and facial hydration as well as markers of photoaging (erythema and pigmentation).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

November 17, 2023

Last Update Submit

November 17, 2023

Conditions

Photoaging

Outcome Measures

Primary Outcomes (2)

  • Change in Skin Elasticity

    Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.)

    8 weeks

  • Change in Skin Hydration

    The skin capacitance will be measured with a handheld non-invasive device (Skin MoistureMeterSC, Delfin Technologies Ltd.). The measurement is in arbitrary units per manufacturer.

    8 weeks

Secondary Outcomes (6)

  • Change in skin pigmentation intensity

    8 weeks

  • Change in appearance of facial wrinkles

    8 weeks

  • Change in the skin erythema

    8 weeks

  • Change in skin transepidermal water loss

    8 weeks

  • Self-perception of skin (changes in facial fine lines and wrinkles, firmness, etc)

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Oral Herbal Supplement

EXPERIMENTAL

Oral supplement containing an herbal blend

Dietary Supplement: Oral herbal supplement

Oral Placebo Supplement

PLACEBO COMPARATOR

Oral placebo supplement

Dietary Supplement: Oral placebo supplement

Interventions

Oral herbal supplementDIETARY_SUPPLEMENT

Take one capsule daily

Oral Herbal Supplement
Oral placebo supplementDIETARY_SUPPLEMENT

Take one capsule daily

Oral Placebo Supplement

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Women who are 35 to 55 years of age

You may not qualify if:

  • Individuals who are pregnant or breastfeeding.
  • Prisoners.
  • Adults unable to consent.
  • Those who are unwilling to discontinue topical probiotics, topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
  • Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
  • Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
  • Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
  • Any known allergy to any of the ingredients in the study product.
  • Those who have been on an oral antibiotic within 1 month prior enrolling
  • Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Laila Afzal

CONTACT

916-524-1216laila@integrativeskinresearch.com

Nasima Afzal

CONTACT

916-524-1216nasima@integrativeskinresearchc.om

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share