Aquagenic Wrinkling Prediction

June 2, 2026 updated by: Philip Polgreen, University of Iowa

Using Aquagenic Wrinkling to Predict CF Carrier State

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

University students

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Potential Cystic Fibrosis Carriers
Participants that are identified as potential cystic fibrosis carriers based on aquagenic wrinkling results.
Procedure: Aquagenic Wrinkling
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
Participants that are identified as potential controls based on aquagenic wrinkling results.
Procedure: Aquagenic Wrinkling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human Observation of Wrinkling
Time Frame: Up to 20 minutes
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
Time Frame: Up to 20 minutes
Photos of hands will be scored by a machine-learning algorithm at each minute.
Up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Philip M Polgreen, MD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 202410028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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