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

NCT04554732 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 1911187141
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Alopecia; Chemotherapy-Induced Change; Hair Loss; Alopecia Drugs

Keywords

Chemotherapy-induced hair loss; Keratinocyte Growth Factor; KGF; Hair loss; Alopecia

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

Secondary Outcomes (9)

• Hair preservation as assessed by participant.

  Four months

• Hair preservation as assessed by physician.

  Four months

• Estimate participant reported comfort.

  Four months

• Evaluate quality of life using EORTC QLQ-C30

  Four months

• Evaluate quality of life using HADS.

  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 factor DRUG

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

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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
• ≥ 21 years of age
• Able to give informed consent

You may not qualify if:

• Female pattern hair loss or hair loss disorder
• Scalp folliculitis
• Scalp psoriasis
• Seborrheic dermatitis
• Inflammatory scalp conditions such as lichen plano-pillaris
• Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
• Unable to provide consent or make allotted clinical visits
• Known allergy to KGF-HS being use in this study

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Pavani Chalasani, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

US (1)