MadarosisPhase 3NCT01200251
Study of Bimatoprost Gel on Eyelash Growth
A Phase 3 study testing Bimatoprost eyelash gel in people with Madarosis and Hypotrichosis, run by Duke University at 1 site in United States.
Trial summary
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Madarosis, Hypotrichosis
- What is being tested?
- Bimatoprost eyelash gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 YO females
- madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
- only breast cancer patients
Who cannot join
- inability to follow up, apply gel
- active eye/eyelid infection or inflammatory process
- cancer not related to breast cancer, healthy patients
- males
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.
- Conditions
- Madarosis, Hypotrichosis
- Being tested
- Bimatoprost eyelash gel
- Medical subject headings
- Hypotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost eyelash gelDrug
Also called lumigan
Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost treated eyelid | Experimental | one eyelid of the patient was randomized to the treatment arm and given the gel to use Receives: Drug: Bimatoprost eyelash gel |
| control arm - no gel | No intervention | the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids |
What is being measured
The primary outcome is the main question the study is designed to answer.
eyelash length
eyelash ruler used to measure eyelash length
Measured: 6 months
Secondary outcomes (4)
eyelash pigment
blinded grader used digital photos to grade degree of pigment on scale of 1-5
Measured: 6 mos
eyelash thickness
blinded grader used digital photos to grade degree of thickness on scale of 1-5
Measured: 6 mos
eyelash amount
blinded grader used digital photos to grade degree of amount by counting lashes
Measured: 6 mos
eyelash side effects
any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed
Measured: 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startFeb 2007
- Primary completionSep 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MadarosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200251
- Sponsor's protocol ID
- 9459
- Other IDs
- 71320
- Status last verified
- Sep 2010
- First submitted
- 10 Sep 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.
PubMed 15577756
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT01200251
- Acronym / sponsor ID
- 9459
- Conditions
- Madarosis, Hypotrichosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Sep 2010 (estimated)
- 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.
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost treated eyelid | Experimental | Drug: Bimatoprost eyelash gelone eyelid of the patient was randomized to the treatment arm and given the gel to use |
| control arm - no gel | No intervention | –the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 YO females
- madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
- only breast cancer patients
Key exclusion criteria (4 listed)
- inability to follow up, apply gel
- active eye/eyelid infection or inflammatory process
- cancer not related to breast cancer, healthy patients
- males
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 |
|---|---|---|
| Bimatoprost eyelash gelAlso: lumiganBimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months | Drug | Bimatoprost treated eyelid |
Primary outcome
eyelash length
Time frame: 6 months
eyelash ruler used to measure eyelash length
4 secondary outcomes
eyelash pigment
Time frame: 6 mos
eyelash thickness
Time frame: 6 mos
eyelash amount
Time frame: 6 mos
eyelash side effects
Time frame: 6 mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Results publication: PubMed 15577756Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.
Related trials for Madarosis
Recruiting
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
Breast Neoplasms, Alopecia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost eyelash gel in people with Madarosis and Hypotrichosis, run by Duke University at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2014. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eyelash length (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200251, which also lists 1 linked publication.
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 16 Jul 2014.