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Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.

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ClinicalTrials.gov Identifier: NCT06020586
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Instituto de Oncología Ángel H. Roffo

Study Description
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Brief Summary:
This is a Phase 2, single-center study designed to determine the effect of ECOHAIR topical solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and investigator reports). A total of 22 subjects are planned to be enrolled, 15 in a prospective single-arm phase in which they will receive the study treatment and 7 controls. Patients should have a clinical diagnosis of chemotherapy-induced alopecia.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Alopecia Other: hair lotion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : December 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: hair lotion Other: hair lotion
ECOHAIR


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of scalp surface area covered at 30 days. [ Time Frame: 30 days ]

    The primary efficacy assessment is hair count in the target area (in a 1 cm2

    circular area) using trichoscopy imaging.


  2. Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp. [ Time Frame: baseline-30 days ]

Secondary Outcome Measures :
  1. Scalp hair density at 30 days. [ Time Frame: 30 days ]
  2. Subject satisfaction questionnare. [ Time Frame: baseline-30 days ]
    questionnaire is related to satisfaction with the outcome of the treatment (lotion).

  3. Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) [ Time Frame: baseline- 60 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women diagnosed with stage I to III breast/ovarian cancer aged 18 to 65 years.
  • Receiving chemotherapeutic agents containing taxanes and/or anthracyclines.
  • Willing to agree to shave thinning hair at baseline.
  • Willingness to be photographed and consent to photographic disclosure.
  • Able to understand and willing to sign an informed consent form.
  • Willing and able to follow all study instructions and attend all study visits.
  • Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on the same maintenance dose throughout the study.
  • If female of childbearing age, must have a negative serum or urine pregnancy test at screnning (visit 0). Use a highly effective method of contraception during the study; do not plan a pregnancy for the duration of the study.

Exclusion Criteria:

  • Use of any products or devices used to promote scalp hair growth (e.g., finasteride or minoxidil, L-tyrosine, cold caps).
  • Sensitivity or allergy to any ingredient in the Ecohair product.
  • Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or history of skin disease on the scalp that, in the opinion of the investigator, may interfere with the efficacy or safety evaluations of the study.
  • Active scalp trauma or other condition affecting the scalp that, in the opinion of the investigator may interfere with the conduct of the study or evaluations.
  • The presence of a permanent or difficult to remove hairpiece or wig that, in the opinion of the investigator, will interfere with study evaluations if not removed at each visit.
  • Failure to be able to perform assigned clinical visits.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020586


Locations
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Argentina
Instituto Roffo Recruiting
Caba, Buenos Aires, Argentina, 1417
Contact: Maria F Guerra    011 5287-5219    mariaflorenciaguerra87@gmail.com   
Contact       mariaflorenciaguerra87@gmail.com   
Principal Investigator: Florencia Guerra, MD         
Sponsors and Collaborators
Instituto de Oncología Ángel H. Roffo
More Information
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Responsible Party: Instituto de Oncología Ángel H. Roffo
ClinicalTrials.gov Identifier: NCT06020586    
Other Study ID Numbers: roffo
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical