Chemotherapy-induced AlopeciaNCT06020586
Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.
A study testing hair lotion in people with Chemotherapy-induced Alopecia, run by Instituto de Oncología Ángel H. Roffo at 1 site in Argentina.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chemotherapy-induced Alopecia
- What is being tested?
- hair lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Jun 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Instituto Roffo
Caba, Buenos Aires, 1417
Maria F Guerra, 011 5287-5219, mariaflorenciaguerra87@gmail.com
mariaflorenciaguerra87@gmail.com
About this study
Official title: Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
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.
- Conditions
- Chemotherapy-induced Alopecia
- Being tested
- hair lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hair lotionOther
ECOHAIR
| Study group | Role | What they receive |
|---|---|---|
| hair lotion | Experimental | Not described Receives: Other: hair lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of scalp surface area covered at 30 days.
The primary efficacy assessment is hair count in the target area (in a 1 cm2
circular area) using trichoscopy imaging.
Measured: 30 days
Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
Measured: baseline-30 days
Secondary outcomes (3)
Scalp hair density at 30 days.
Measured: 30 days
Subject satisfaction questionnare.
questionnaire is related to satisfaction with the outcome of the treatment (lotion).
Measured: baseline-30 days
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)
Measured: baseline- 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start6 Jun 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oncología Ángel H. Roffo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020586
- Sponsor's protocol ID
- roffo
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
- ClinicalTrials.gov ID
- NCT06020586
- Acronym / sponsor ID
- roffo
- Conditions
- Chemotherapy-induced Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Instituto de Oncología Ángel H. RoffoUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hair lotion | Experimental | Other: hair lotion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hair lotionECOHAIR | Other | hair lotion |
Primary outcome
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.
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
3 secondary outcomes
Scalp hair density at 30 days.
Time frame: 30 days
Subject satisfaction questionnare.
Time frame: baseline-30 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hair lotion in people with Chemotherapy-induced Alopecia, run by Instituto de Oncología Ángel H. Roffo at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of scalp surface area covered at 30 days. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.