NCT06096649

Brief Summary

This study is a double-blind randomized vehicle-controlled study assessing how Zinc Di-(dibutyryl lisinate) (Z-DBL) influences skin biophysical measures such as skin hydration, transepidermal water loss, and elasticity, as well as its effects on the skin microbiome of photoaged skin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

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

October 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 12, 2023

Last Update Submit

October 17, 2023

Conditions

Photoaging

Keywords

skin microbiomeskin biophysical propertiesphotoagingzinc di-(dibutyryl lisinate)

Outcome Measures

Primary Outcomes (2)

  • Change in image analysis based pigment intensity

    Facial photographs will be analyzed for pigment intensity for the face after the photographs are obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The pigment intensity will be measured as a relative change from baseline and is a dimensionless and normalized measure.

    8 weeks

  • 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 image analysis based wrinkle severity

    8 weeks

  • Shifts in the skin microbiome diversity

    8 weeks

  • Changes in skin barrier biomarkers like filaggrin

    8 weeks

  • Product tolerability

    8 weeks

  • Change in skin elasticity

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Topical Vehicle + Zinc Di-(dibutyryl lisinate)

EXPERIMENTAL

Topical cream containing Zinc Di-(dibutyryl listinate)

Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Topical Vehicle

PLACEBO COMPARATOR

Topical cream

Other: Topical Vehicle

Interventions

Topical Vehicle + Zinc Di-(dibutyryl lisinate)OTHER

Instructions: Apply to the entire face twice daily - morning and evening

Topical Vehicle + Zinc Di-(dibutyryl lisinate)
Topical VehicleOTHER

Instructions: Apply to the entire face twice daily - morning and evening

Topical Vehicle

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females between the ages of 40 years of age until 60 years of age
  • Participants must have facial fine lines and wrinkles
  • Subjects must minimize sun exposure
  • Subjects must avoid professional or facial spa procedures during the study

You may not qualify if:

  • Individuals who are pregnant or breastfeeding.
  • Prisoners.
  • Adults unable to consent.
  • Those who are unwilling to discontinue topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
  • Those who are unwilling to discontinue topical antibiotics and benzoyl peroxide for two weeks to meet the washout criteria prior to enrolling.
  • Those who have been on an oral antibiotic within 1 month 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.
  • Those who are unwilling to discontinue all facial topical products except the product provided in the study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95819, United States

Location

Central Study Contacts

Raja K. Sivamani, MD

CONTACT

916-524-1216research@integrativeskinresearch.com

Nasima Afzal

CONTACT

nasima@integrativeskinresearchc.om

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Zinc Di-(dibutyryl lisinate) vs Vehicle
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 24, 2023

Study Start

October 15, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)