A Phase 4 interventional study of Eflornithine cream 11.5 w/w % in Hirsutism, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-02.
Sponsored by Bispebjerg Hospital · Phase 4, Interventional, and Treatment
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.
41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.
This study's enrollment of 22 is below the median of 43 across 26 interventional studies indexed under Hirsutism.
Browse Hirsutism studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 %
Drug page: Eflornithine
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
Also known as: Vaniqa
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
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
The record gives a start of Jan 2012, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eflornithine