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

• Status: Recruiting
• Trial end date: 2023-11-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Mitogens

Criteria

Inclusion Criteria:

1. Diagnosed with early stage breast cancer (stage I-III)

2. Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy

3. ≥ 21 years of age

4. Able to give informed consent

Exclusion Criteria:

1. Female pattern hair loss or hair loss disorder

2. Scalp folliculitis

3. Scalp psoriasis

4. Seborrheic dermatitis

5. Inflammatory scalp conditions such as lichen plano-pillaris

6. Subjects wearing wigs or subjects who shave their hair prior to chemotherapy

7. Unable to provide consent or make allotted clinical visits

8. Known allergy to KGF-HS being use in this study