Hirsutism
Conditions
Keywords
Unwanted facial hair growth
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.
Interventions
DRUGEflornithine cream 11.5 w/w %
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
Sponsors
Bispebjerg Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's overall satisfaction | Baseline, 1, 3 and 6 months | Based on a VAS scale (0-10) |
| Patient's assessment of efficacy | Baseline, 1, 3 and 6 months | 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) |
| Doctors blinded on-site evaluation of efficacy | Baseline, 1, 3 and 6 months | 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) |
| Doctor's on-site blinded assessment of adverse events | Baseline, 1,3 and 6 months | Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale: 1. none 2. mild 3. moderate 4. severe Other observed side effects will also be registered and rated |
| Patient's overall impression of efficacy | Baseline, 1,3 and 6 months | Assessment of the patients impression of difference between two sides of the face on a four-point scale: 1. No difference 2. little difference 3. large difference 4. significant difference, complete or almost complete clearance of hair on treated side. |
| Patient's assessment of adverse events | Baseline, 1, 3 and 6 months | Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale: 1. none 2. mild 3. moderate 4. severe Other observed side effects will also be registered and rated |
Countries
Denmark
Outcome results
None listed