Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
Primary Purpose
Hirsutism
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Eflornithine cream 11.5 w/w %
Sponsored by
About this trial
This is an interventional treatment trial for Hirsutism focused on measuring Unwanted facial hair growth
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- habile, understands Danish
- moderate to severe hirsutism prior to laser treatments
- succeeded minimum five laser treatments
- intact skin with no severe adverse events to laser treatments
- record of current medication and androgen hormone blood profile available
- Use of safe anti-conception (fertile women)
Exclusion Criteria:
- Pregnant or lactating
- allergy toward the content of Eflornithin cream
- Concomitant use of immunosuppressive therapy
- Dementia, psychiatric disease, alcoholic
Sites / Locations
- Dermatological Dep Bispebjerg Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
split-face eflornithin vs. no treatment
Arm Description
Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months
Outcomes
Primary Outcome Measures
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
Secondary Outcome Measures
Doctors blinded on-site evaluation of efficacy
Based on a four-point scale used on both sides of the face separately:
no effect
small effect (clearly visible hairs on evaluated side)
large effect (minimal hair on evaluated side)
significant effect (none or next to no hair on evaluated side)
Patient's overall satisfaction
Based on a VAS scale (0-10)
Patient's assessment of efficacy
Based on a four-point scale used on both sides of the face separately:
no effect
small effect (clearly visible hairs on evaluated side)
large effect (minimal hair on evaluated side)
significant effect (none or next to no hair on evaluated side)
Patient's assessment of adverse events
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
none
mild
moderate
severe Other observed side effects will also be registered and rated
Doctor's on-site blinded assessment of adverse events
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
none
mild
moderate
severe Other observed side effects will also be registered and rated
Patient's overall impression of efficacy
Assessment of the patients impression of difference between two sides of the face on a four-point scale:
No difference
little difference
large difference
significant difference, complete or almost complete clearance of hair on treated side.
Full Information
NCT ID
NCT01817894
First Posted
February 14, 2013
Last Updated
November 29, 2013
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01817894
Brief Title
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
Official Title
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.
Detailed Description
Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.
Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.
Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsutism
Keywords
Unwanted facial hair growth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
split-face eflornithin vs. no treatment
Arm Type
Other
Arm Description
Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months
Intervention Type
Drug
Intervention Name(s)
Eflornithine cream 11.5 w/w %
Other Intervention Name(s)
Vaniqa
Intervention Description
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
Primary Outcome Measure Information:
Title
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
Time Frame
baseline, 1, 3 and 6 months
Secondary Outcome Measure Information:
Title
Doctors blinded on-site evaluation of efficacy
Description
Based on a four-point scale used on both sides of the face separately:
no effect
small effect (clearly visible hairs on evaluated side)
large effect (minimal hair on evaluated side)
significant effect (none or next to no hair on evaluated side)
Time Frame
Baseline, 1, 3 and 6 months
Title
Patient's overall satisfaction
Description
Based on a VAS scale (0-10)
Time Frame
Baseline, 1, 3 and 6 months
Title
Patient's assessment of efficacy
Description
Based on a four-point scale used on both sides of the face separately:
no effect
small effect (clearly visible hairs on evaluated side)
large effect (minimal hair on evaluated side)
significant effect (none or next to no hair on evaluated side)
Time Frame
Baseline, 1, 3 and 6 months
Title
Patient's assessment of adverse events
Description
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
none
mild
moderate
severe Other observed side effects will also be registered and rated
Time Frame
Baseline, 1, 3 and 6 months
Title
Doctor's on-site blinded assessment of adverse events
Description
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
none
mild
moderate
severe Other observed side effects will also be registered and rated
Time Frame
Baseline, 1,3 and 6 months
Title
Patient's overall impression of efficacy
Description
Assessment of the patients impression of difference between two sides of the face on a four-point scale:
No difference
little difference
large difference
significant difference, complete or almost complete clearance of hair on treated side.
Time Frame
Baseline, 1,3 and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
habile, understands Danish
moderate to severe hirsutism prior to laser treatments
succeeded minimum five laser treatments
intact skin with no severe adverse events to laser treatments
record of current medication and androgen hormone blood profile available
Use of safe anti-conception (fertile women)
Exclusion Criteria:
Pregnant or lactating
allergy toward the content of Eflornithin cream
Concomitant use of immunosuppressive therapy
Dementia, psychiatric disease, alcoholic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth H Taudorf, MD
Organizational Affiliation
BispbejergH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatological Dep Bispebjerg Hospital
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
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