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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-face eflornithin vs. no treatment | Other | Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eflornithine cream 11.5 w/w % | Drug | Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months |
|
| 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 |
| 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:
| Baseline, 1, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth H Taudorf, MD | BispbejergH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatological Dep Bispebjerg Hospital | Copenhagen NV | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D006628 | Hirsutism |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
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| ID | Term |
|---|---|
| D000518 | Eflornithine |
| ID | Term |
|---|---|
| D009952 | Ornithine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| 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:
| 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:
| 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:
| 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:
| Baseline, 1,3 and 6 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000599 |
| Amino Acids, Diamino |