Clinical trial NCT01817894: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hirsutism
Keywords: Unwanted facial hair growth
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
timeFrame: baseline, 1, 3 and 6 months
Secondary outcomes:
measure: Doctors blinded on-site evaluation of efficacy
timeFrame: Baseline, 1, 3 and 6 months
measure: Patient's overall satisfaction
timeFrame: Baseline, 1, 3 and 6 months
measure: Patient's assessment of efficacy
timeFrame: Baseline, 1, 3 and 6 months
measure: Patient's assessment of adverse events
timeFrame: Baseline, 1, 3 and 6 months
measure: Doctor's on-site blinded assessment of adverse events
timeFrame: Baseline, 1,3 and 6 months
measure: Patient's overall impression of efficacy
timeFrame: Baseline, 1,3 and 6 months
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Dermatological Dep Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: BispbejergH
name: Elisabeth H Taudorf, MD
role: PRINCIPAL_INVESTIGATOR
References: