Aquagenic Wrinkling Prediction

NCT06831110 | Recruiting

• 1 other identifier: 202410028
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine whether an aquagenic wrinkling procedure (i.e., soaking hands in a water bath for up to 20 minutes) can be used as a screening tool for cystic fibrosis carrier status. Participants will complete one visit where they will undergo an aquagenic wrinkling procedure to see how their hands respond.

Conditions

Aquagenic Wrinkling of Palms; Carrier State

Outcome Measures

Primary Outcomes (2)

• Human Observation of Wrinkling

  Photos of hands will be scored on a scale of 0 (no wrinkling) to 4 (severe wrinkling) at each minute by human observers.

  Up to 20 minutes

• Machine-Learning Observation of Wrinkling

  Photos of hands will be scored by a machine-learning algorithm at each minute.

  Up to 20 minutes

Study Arms (2)

Potential Cystic Fibrosis Carriers

Participants that are identified as potential cystic fibrosis carriers based on aquagenic wrinkling results.

Procedure: Aquagenic Wrinkling

Potential Controls

Participants that are identified as potential controls based on aquagenic wrinkling results.

Procedure: Aquagenic Wrinkling

Interventions

Aquagenic Wrinkling PROCEDURE

Participants will be asked to remove all jewelry from the hand(s) and wrist(s) that will be undergoing the aquagenic wrinkling procedures. Photographs will be taken of the palmar surface of the hand(s). The participant will submerge the hand(s) undergoing testing in a water bath for one minute. After one minute, they will remove their hand(s), dry them gently with a towel, and photographs will be taken of the palmar surface of the hand(s). The participant will re-submerge their hand(s) in the appropriate conditions for another minute and the process will be repeated 20 times for 20 total minutes submerged in the water.

Potential Controls; Potential Cystic Fibrosis Carriers

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University students

You may qualify if:

• Interested in participating in other CF Carrier-related research studies.

You may not qualify if:

• CF patient status
• Unable to speak English
• Unable to provide written informed consent
• Prisoner status
• An open wound on either hand
• A tattoo on either hand
• Missing any portion of either hand
• Diagnosis of Diabetes
• Diagnosis of Hyperhidrosis
• Diagnosis of Raynaud's Disease
• Diagnosis of Atopic Dermatitis
• Regularly taking ACE inhibitors or angiotensin receptor blockers

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Study Officials

• Philip M Polgreen, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip M Polgreen, MD

CONTACT

319-384-6194; philip-polgreen@uiowa.edu

Shelby L Francis, PhD

CONTACT

319-678-8037; shelby-francis@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 17, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)