Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Hirsutism

Treatments: Drug: Eflornithine cream 11.5 w/w %

Study type: Interventional

Funder types: Other

Identifiers

NCT01817894

H-2-2011-139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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22 participants in 1 patient group

split-face eflornithin vs. no treatment

Other group

Description:

Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months

Treatment:

Drug: Eflornithine cream 11.5 w/w %