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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hirsutism

Intervention / Treatment
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* Drug: Eflornithine cream 11.5 w/w %


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: split-face eflornithin vs. no treatment<br>Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months | Drug: Eflornithine cream 11.5 w/w %<br>* Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months<br>* Other names: Vaniqa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field |  | baseline, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline, 1, 3 and 6 months | 
| Patient's overall satisfaction | Based on a VAS scale (0-10) | Baseline, 1, 3 and 6 months | 
| 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) | Baseline, 1, 3 and 6 months | 
| 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 | Baseline, 1, 3 and 6 months | 
| 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 | Baseline, 1,3 and 6 months | 
| 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. | Baseline, 1,3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unwanted facial hair growth