MedTrace Logo

Keratinocyte Growth Factor- Hair Serum for the Prevention of Chemotherapy Induced Alopecia

NCT04554732 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-12-16

No results posted yet for this study

Summary

Primary aim is to provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia.

Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. The investigators will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale.

Conditions

Interventions

DRUG

Keratinocyte growth factor

At the end of 4 cycles of chemotherapy, primary efficacy end point data will be collected. After 20 evaluable subjects if ≥ 4 responses were noted, part 2 of the study will be activated. The decision rule is based on the lower bound of a one-sided 95% confidence interval; at least 4 out of 20 patients with response results in a lower bound greater than 5% success. The proportion with success and the lower bound of a one-sided exact confidence interval will be computed.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Pavani Chalasani, MD · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2022-06-24
Completion
2022-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554732 on ClinicalTrials.gov