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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
Dermatological Dep Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
Time frame: baseline, 1, 3 and 6 months
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)
Time frame: Baseline, 1, 3 and 6 months
Patient's overall satisfaction
Based on a VAS scale (0-10)
Time frame: 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)
Time frame: 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: 1. none 2. mild 3. moderate 4. severe Other observed side effects will also be registered and rated
Time frame: 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: 1. none 2. mild 3. moderate 4. severe Other observed side effects will also be registered and rated
Time frame: Baseline, 1,3 and 6 months
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Patient's overall impression of efficacy
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.
Time frame: Baseline, 1,3 and 6 months