HypotrichosisPhase 4NCT01891487
Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Thinning Eyebrows
A Phase 4 study testing Track A and Track B in people with Hypotrichosis, run by ATS Clinical Research at 1 site in United States.
Trial summary
This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects eyebrow for duration of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotrichosis
- What is being tested?
- Track A and Track B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2015
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males, ages 18-75 years with brows that are naturally thinning with a score of 1 (very thin) or 2 (thin) at baseline as determined by the Investigator Global Eyebrow Assessment (IGEA).
- Subjects who agree to forgo any additional treatment to the brows, such as waxing, plucking, threading and/or tinting for the duration of the study.
- Desires to participate in a research study
Who cannot join
- Any uncontrolled systemic disease.
- Any known diseases or abnormalities to the eyelid or eyebrow.
- Known allergies or reactions to bimatoprost or placebo ingredients.
- Pregnancy.
- Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss.
- Subjects who have used any over the counter or prescription eyebrow growth product 3 months prior to baseline.
Show all 12Show fewer
- Subjects with tattooed eyebrows and/or any permanent or semi-permanent tint or dye within 3 months prior to baseline.
- Subjects with a score of 3 or 4 on the eyebrow scale.
- Current enrollment in an investigational drug or device study or participation in such a study 30 days prior to baseline.
- Subjects using prostaglandin analogs for the treatment of high intraocular pressure.
- Aphakic subjects and/or pseudophakic subjects with a torn posterior lens capsule.
- Subjects with known risk factors for macular edema.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Eyebrow Hypotrichosis: A Phase 4 Investigator Initiated Study
This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects eyebrow for duration of the study.
Read the detailed description
A parallel, placebo-controlled, single-center, prospective, randomized, double blind, pilot trial to demonstrate bimatoprost 0.03% efficacy in eyebrow hypotrichosis in otherwise healthy individuals with thinning eyebrows. Bimatoprost 0.03% or placebo will be applied to the eyebrow margin once daily for 36 weeks. Adverse events will be assessed, and subjects will complete outcomes questionnaires at study visits. Eyebrow growth and darkening will be scored by the investigator and photography will be taken at each study visit.
Eyebrows are generally composed of three types of hairs: fine vellus hairs are the smallest, with the second type slightly larger, lightly pigmented hairs. The supercilia are the large terminal hairs which are the most visible and are primarily responsible for color and shape of the brow. Eyelashes are composed of terminal hairs, and it has been well demonstrated that bimatoprost application on these hairs will render them longer, thicker and darker (Allergan Protocol 192024-032). It has also been demonstrated that bimatoprost will darken vellus hair, making them more visible. It may be that administering bimatoprost to the eyebrows will cause the terminal hair to become longer, thicker and darker, and make the vellus and lightly pigmented hairs become more noticeable, thus increasing the intensity and fullness of the entire brow.
Multiple studies have been conducted to assess the safety and efficacy of the application of bimatoprost solution to the eyelid for growth of natural eyelashes (Yoelin S, et al, 2010). In 2 active-controlled phase 3 studies for LUMIGAN®, eyelash growth was reported as an adverse event after 3 months of treatment of subjects receiving bimatoprost once daily (Allergan Studies 192024-008 and 192024-009). The application of bimatoprost solution to the eyelid has proven to be effective in enhancing eyelash growth in women when applied daily for 12 weeks (Cohen JL, 2010).
This drug effect has been formally acknowledged in the LUMIGAN® package insert (Appendix 5.2) further supporting the bimatoprost's effect on eyelash growth. The package insert indicates that LUMIGAN® may gradually change eyelashes with regard to increased length, thickness, pigmentation, and number of eyelashes. Since its US approval in 2001, several adverse events of "growth of eyelashes" have been reported in conjunction with the use of LUMIGAN®.
Subjects will be randomized to Track A, active study drug, bimatoprost 0.03% solution, or to Track B, placebo. Each track will apply the same dose, 1 drop per eyebrow once daily, to determine the safety and efficacy of bimatoprost 0.03% solution versus placebo.
- Conditions
- Hypotrichosis
- Being tested
- Track A, Track B
- Keywords
- Eyebrow, Hypotrichosis, Thinning, Bimatoprost
- Medical subject headings
- Hypotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Track ADrug
Also called Active study drug, Bimatoprost 0.03% solution
Bimatoprost 0.03% solution applied to eyebrow
Track BDrug
Also called Placebo control group, Refresh Tears
Refresh Tears applied to eyebrows
| Study group | Role | What they receive |
|---|---|---|
| Track A | Active comparator | Those on active study medication Receives: Drug: Track A |
| Track B | Placebo comparator | Those on placebo. Receives: Drug: Track B |
What is being measured
The primary outcome is the main question the study is designed to answer.
One grade improvement at week 16, 24 and 36 as based on the IGEA
Target area of both left and right eyebrow will be examined for a one grade improvement based on the Investigator Global Eyebrow Assessment (IGEA) (section 17 of protocol) at baseline, week 16, 24 and 36 for Track A and Track B subjects. Target area is delineated by the mid-pupillary line to the lateral canthus.
Measured: Week 16, 24 and 36
Secondary outcomes (1)
Grade improvement based on IEA4 at week 16, 24 and 36
Intensity (defined as thickness, darkness and hair quantity) of the target area of both left and right eyebrow based on the Investigator Eyebrow Assessment 4 Point Brow Scale at baseline, week 16, 24 and 36 for Track A and Track B subjects. Subject satisfaction with their brows (PRO measure) at week 36 for Track A Track B. Frequency and severity of adverse events.
Measured: Week 16, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypotrichosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATS Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Ava Shamban, MD, Principal investigator, ATS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891487
- Sponsor's protocol ID
- ATSBROW-001
- Status last verified
- Jan 2015
- First submitted
- 28 Jun 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Allergan Protocol 192024-032, June 2008 Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence.
Allergan Protocol 192024-008 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution, administered once- daily or twice-daily compared with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].
Allergan Protocol 192024-009 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution administered once-daily or twice daily compare with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].
Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x.
PubMed 20384750Yoelin S, Walt JG, Earl M. Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth. Dermatol Surg. 2010 May;36(5):638-49. doi: 10.1111/j.1524-4725.2010.01519.x. Epub 2010 Apr 1.
PubMed 20384751
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Eyebrow Hypotrichosis: A Phase 4 Investigator Initiated Study
- ClinicalTrials.gov ID
- NCT01891487
- Acronym / sponsor ID
- ATSBROW-001
- Conditions
- Hypotrichosis
- Keywords
- Eyebrow, Hypotrichosis, Thinning, Bimatoprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ATS Clinical ResearchUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Jul 2013 (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.
This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects eyebrow for duration of the study.
Detailed description
A parallel, placebo-controlled, single-center, prospective, randomized, double blind, pilot trial to demonstrate bimatoprost 0.03% efficacy in eyebrow hypotrichosis in otherwise healthy individuals with thinning eyebrows. Bimatoprost 0.03% or placebo will be applied to the eyebrow margin once daily for 36 weeks. Adverse events will be assessed, and subjects will complete outcomes questionnaires at study visits. Eyebrow growth and darkening will be scored by the investigator and photography will be taken at each study visit.
Eyebrows are generally composed of three types of hairs: fine vellus hairs are the smallest, with the second type slightly larger, lightly pigmented hairs. The supercilia are the large terminal hairs which are the most visible and are primarily responsible for color and shape of the brow. Eyelashes are composed of terminal hairs, and it has been well demonstrated that bimatoprost application on these hairs will render them longer, thicker and darker (Allergan Protocol 192024-032). It has also been demonstrated that bimatoprost will darken vellus hair, making them more visible. It may be that administering bimatoprost to the eyebrows will cause the terminal hair to become longer, thicker and darker, and make the vellus and lightly pigmented hairs become more noticeable, thus increasing the intensity and fullness of the entire brow.
Multiple studies have been conducted to assess the safety and efficacy of the application of bimatoprost solution to the eyelid for growth of natural eyelashes (Yoelin S, et al, 2010). In 2 active-controlled phase 3 studies for LUMIGAN®, eyelash growth was reported as an adverse event after 3 months of treatment of subjects receiving bimatoprost once daily (Allergan Studies 192024-008 and 192024-009). The application of bimatoprost solution to the eyelid has proven to be effective in enhancing eyelash growth in women when applied daily for 12 weeks (Cohen JL, 2010).
This drug effect has been formally acknowledged in the LUMIGAN® package insert (Appendix 5.2) further supporting the bimatoprost's effect on eyelash growth. The package insert indicates that LUMIGAN® may gradually change eyelashes with regard to increased length, thickness, pigmentation, and number of eyelashes. Since its US approval in 2001, several adverse events of "growth of eyelashes" have been reported in conjunction with the use of LUMIGAN®.
Subjects will be randomized to Track A, active study drug, bimatoprost 0.03% solution, or to Track B, placebo. Each track will apply the same dose, 1 drop per eyebrow once daily, to determine the safety and efficacy of bimatoprost 0.03% solution versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Track A | Active comparator | Drug: Track AThose on active study medication |
| Track B | Placebo comparator | Drug: Track BThose on placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females and males, ages 18-75 years with brows that are naturally thinning with a score of 1 (very thin) or 2 (thin) at baseline as determined by the Investigator Global Eyebrow Assessment (IGEA).
- Subjects who agree to forgo any additional treatment to the brows, such as waxing, plucking, threading and/or tinting for the duration of the study.
- Desires to participate in a research study
Key exclusion criteria (12 listed)
- Any uncontrolled systemic disease.
- Any known diseases or abnormalities to the eyelid or eyebrow.
- Known allergies or reactions to bimatoprost or placebo ingredients.
- Pregnancy.
- Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss.
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 |
|---|---|---|
| Track AAlso: Active study drug, Bimatoprost 0.03% solutionBimatoprost 0.03% solution applied to eyebrow | Drug | Track A |
| Track BAlso: Placebo control group, Refresh TearsRefresh Tears applied to eyebrows | Drug | Track B |
Primary outcome
One grade improvement at week 16, 24 and 36 as based on the IGEA
Time frame: Week 16, 24 and 36
Target area of both left and right eyebrow will be examined for a one grade improvement based on the Investigator Global Eyebrow Assessment (IGEA) (section 17 of protocol) at baseline, week 16, 24 and 36 for Track A and Track B subjects. Target area is delineated by the mid-pupillary line to the lateral canthus.
1 secondary outcome
Grade improvement based on IEA4 at week 16, 24 and 36
Time frame: Week 16, 24 and 36
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 14 Jan 2015.
- BackgroundAllergan Protocol 192024-032, June 2008 Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence.
- Results publicationAllergan Protocol 192024-008 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution, administered once- daily or twice-daily compared with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].
- Results publicationAllergan Protocol 192024-009 A multicenter, double-masked, randomized, parallel, three-month study (with treatment extended to one year) of the safety and efficacy of ANG 192024 0.03% ophthalmic solution administered once-daily or twice daily compare with timolol 0.5% ophthalmic solution administered twice-daily, in subjects with glaucoma or ocular hypertension [12 month report].
- Results publication: PubMed 20384750Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x.
- Results publication: PubMed 20384751Yoelin S, Walt JG, Earl M. Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth. Dermatol Surg. 2010 May;36(5):638-49. doi: 10.1111/j.1524-4725.2010.01519.x. Epub 2010 Apr 1.
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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.
Ava Shamban, MD principal investigator
ATS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Track A and Track B in people with Hypotrichosis, run by ATS Clinical Research 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 12 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 14 Jan 2015. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
One grade improvement at week 16, 24 and 36 as based on the IGEA (time frame: Week 16, 24 and 36). 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 NCT01891487, which also lists 5 linked publications.
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 14 Jan 2015.