Trials Sponsors Conditions Drugs Pricing

Conditions

Alopecia Alopecia Drugs Chemotherapy-Induced Change Hair Loss

Keywords

Chemotherapy-induced hair lossKeratinocyte Growth FactorKGFHair lossAlopecia

Outcome Measures

Primary Outcomes (2)

Part 1: Preliminary assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. We will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale: Grade 1 = Hair loss of \<50% of normal; Grade 2 = Hair loss of \>50% of normal.
Four months
Part 2: Randomized, placebo-controlled assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
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. We will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale: Grade 1 = Hair loss of \<50% of normal; Grade 2 = Hair loss of \>50% of normal.
Four months

Study Arms (1)

Part 1 - Initial group treatment

EXPERIMENTAL

For part 1 of the study, subjects will be enrolled into a prospective single arm phase where all of them get the study treatment. We plan to enroll up to 25 subjects to have 20 evaluable subjects to this phase.

Drug: Keratinocyte growth factor

Interventions

Keratinocyte growth factorDrug

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.

Part 1 - Initial group treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosed with early stage breast cancer (stage I-III)
Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy

Sponsors & Collaborators

University of Arizona
Otherlead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Related Publications (1)

Mann K, Potluri P, Paul EE, Segar JM, Ehsani S, Roe D, Chalasani P. A Nonrandomized Clinical Trial Investigating Keratinocyte Growth Factor-Hair Serum for the Prevention of Chemotherapy-Induced Alopecia. J Cosmet Dermatol. 2026 Mar;25(3):e70797. doi: 10.1111/jocd.70797.
PMID: 41834767DERIVED

MeSH Terms

Conditions

Alopecia

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

Pavani Chalasani, MD
University of Arizona
PRINCIPAL INVESTIGATOR

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

August 5, 2020

First Posted

September 18, 2020

Study Start

April 27, 2020

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Part 1 - Initial group treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (9)

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Part 1 - Initial group treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (9)

You may not qualify if:

Source record

Locations