Recruiting

Steroid Cream

Sponsor:

Baylor College of Medicine

Code:

NCT07508124

Conditions

Urinary Tract Infection

Eligibility Criteria

Sex: Male

Age: 0

Healthy Volunteers: Not accepted

Interventions

betamethasone valerate 0.1% cream

Placebo cream

Study Details

Brief summary:

The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised.

Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.

Conditions

Urinary Tract Infection

Study ID

NCT07508124

Start date

May 8, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Uncircumcised male infants < 6 months old
2. Both physician and laboratory confirmed diagnosis of first UTI
3. Fever (temperature ≥38.0 C) or hypothermia (temperature <36.0 C) per ED/hospitalization or parental report

Exclusion Criteria:

1. Legal guardian not available to provide informed consent
2. Infant in Child Protective Services (CPS) custody
3. Legal guardian would like Urology referral for circumcision
4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
6. Prior use of topical steroid therapy for phimosis
7. History of hypersensitivity to topical steroids
8. Legal guardian is not fluent in English OR Spanish
9. Foreskin assessed to be fully retractable
10. Open wounds present on penis or in groin region

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Participants randomized to receive steroid cream

placebo comparator: Participants randomized to receive placebo cream.

Interventions

betamethasone valerate 0.1% cream

Steroid cream applied to the foreskin and glans twice a day for four weeks.

Placebo cream

Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Primary outcome measure

  • Feasibility of recruitment across different settings [ Time Frame: up to 2 weeks ]

Central Contacts and Locations

Central contacts

Sowdhamini Wallace, DO, MS

18328245447swallace@bcm.edu

Locations

Texas Children's Hospital Main campus

Recruiting

Houston, Texas, United States, 77030

Contacts

Sowdhamini Wallace, DO, MS

832-824-5447swallace@bcm.edu

Principal Investigator:

Sowdhamini Wallace, DO, MS

More Information

Sponsor

Baylor College of Medicine

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • urinary tract infection
  • uncircumcised male infants
  • betamethasone cream
  • steroid cream

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-08-07.