Topical Tartrazine for Improved Skin Structure Visualization in Dermatology

NCT06800183 | Withdrawn Early Phase 1

• 1 other identifier: IRB00469443
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the topical application of tartrazine, an FDA-approved food dye, can help improve the transparency of the skin in healthy volunteers. The main questions it aims to answer are:

• Can topical tartrazine application allow for temporary skin transparency?
• What dose of tartrazine is required to achieve reversible skin transparency? Participants will:
• Be given a patch test with four different doses of tartrazine
• Have these patch tests placed on the back, stomach, and forearm
• Have photographs taken every 5 minutes to see if transparency is achieved
• Be called 48 hours later to check for any side effects

Conditions

Healthy; Dermoscopy; Optical Imaging

Keywords

Tartrazine; optical transparency; dermoscopy

Outcome Measures

Primary Outcomes (1)

• Optical Transparency as Assessed by Total Transmittance Percentage

  To determine the optimal duration for maximum transparency, serial imaging will be conducted over the course of one 90 minute clinic visit (baseline, immediately post-application, and at 5-minute intervals until transparency plateaus). Imaging will be performed using non-invasive modalities. High-resolution dermoscopy will capture clear images of skin structures, and standardized high-quality photography will document the visible effects of transparency. These images will assess improvements in the resolution, depth, and overall image quality of subdermal structures, allowing the investigators to evaluate whether tartrazine significantly enhances visualization.

  Up to 90 minutes

Study Arms (1)

Tartrazine Patch with 4 Doses across 3 Body Sites

EXPERIMENTAL

A four-chamber patch will be loaded with 0.5militer (mL) of tartrazine and applied to 1 cm diameter areas on the skin. Each chamber will deliver one of four different concentrations of a tartrazine solution-0.15 molar concentration (M), 0.3M, 0.6M, and 1.2M-on three distinct skin regions: the anterior forearm (representing thin skin), the abdomen (representing medium-thickness skin), and the back (representing thicker skin). This method ensures consistent, standardized, and simultaneous applications across all skin types and participants, reducing variability in the application process.

Drug: Four-Chamber Tartrazine Patch across 3 Body Sites

Interventions

Four-Chamber Tartrazine Patch across 3 Body Sites DRUG

This is a chamber patch comprising four increasing doses of tartrazine (0.15M, 0.3M, 0.6M, 1.2M). This will be applied on the forearm, abdomen, and back to represent different skin thicknesses.

Also known as: FD&C Yellow 5, E102

Tartrazine Patch with 4 Doses across 3 Body Sites

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 18 and older
• Willingness to comply with study procedures
• Able to provide informed consent

You may not qualify if:

• Known allergies to tartrazine or related compounds
• Current or history of skin conditions such as eczema, psoriasis, or severe inflammatory diseases, defined as scoring ≥16 on the Eczema Area and Severity Index (EASI) or ≥10 on the Psoriasis Area Severity Index (PASI)
• Other atopic conditions such as asthma, allergic rhinitis, or hypersensitivity reactions
• Pregnancy or breastfeeding
• Use of immunosuppressive medications
• Any condition that may interfere with the safety or results of the study

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Ntziachristos V. Going deeper than microscopy: the optical imaging frontier in biology. Nat Methods. 2010 Aug;7(8):603-14. doi: 10.1038/nmeth.1483. Epub 2010 Jul 30.

  PMID: 20676081 RESULT

• Ou Z, Duh YS, Rommelfanger NJ, Keck CHC, Jiang S, Brinson K Jr, Zhao S, Schmidt EL, Wu X, Yang F, Cai B, Cui H, Qi W, Wu S, Tantry A, Roth R, Ding J, Chen X, Kaltschmidt JA, Brongersma ML, Hong G. Achieving optical transparency in live animals with absorbing molecules. Science. 2024 Sep 6;385(6713):eadm6869. doi: 10.1126/science.adm6869. Epub 2024 Sep 6.

  PMID: 39236186 RESULT

MeSH Terms

Interventions

Tartrazine

Intervention Hierarchy (Ancestors)

Azo Compounds; Organic Chemicals

Study Officials

• Joel Sunshine, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)