A Phase 1/2 interventional study of FOL-005 and Placebo in Hypertrichosis, Alopecia and Hirsutism, sponsored by Follicum AB. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Follicum AB · Phase 1/2, Interventional, and Treatment
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
SAD part:
A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.
MD part:
In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly
Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Follicum AB is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.
Other: Placebo
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Jan 2016, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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