Demodex folliculorum Infections and Infestations Demodex folliculorum
Conditions
Interventions
1. Treatment administration:
The application of the magistral formula (FM) and the shampoo control treatment (ChB) will be in charge of the principal investigator. There won´t be difference according
for this purpose the products commercial presentations and organoleptic properties will be adjusted, so that neither the patient nor the doctor could identify the treatment group.
The eyelids of the a
Sponsors
Laboratorios procaps S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and not pregnant or lactating women = 18 years of age 2. Blepharitis Acarida by Demodex sp clinical diagnosis 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Current or recent (two weeks prior) treatment against Demodex sp 2. Oral or topic steroids consumption 3. Immunosuppressive disease medical history 4. Mental illness that does not allow an assessment of symptoms 5. Any illness that eventually requires hospitalization 6. History of malignant disease 7. Hypersensitivity to any of formulation ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demodex infestation index: To determine the presence of mites 4 eyelashes per eye will be extracted under slit lamp with a watchmaker forceps, alternating between upper and lower eye lid. Once removed, the eyelashes will be mounted onto glass slide and observed in the CHT ® Olympus microscope with objectives 4x, 10x, 40x; the count is conducted with the objective of 4x and counted equally all stages of mite. Subsequently the parasite index mites/eyelash will be calculated by dividing the number of mites found on the total observed eyelashes. The IP will be considered positive if = 0.5. The finding of 4 – 5 demodex mites will be interpreted as an intense parasite degree. The existence of a single mite in all eyelashes won’t be interpreted as significant infection data. In subsequent monitoring (day 7 and 21 post-treatment) only will be necessary to remove one eyelash per lid, 4 per evaluation. The growth of eyelashes is 21 days on average, a total of 20 eyelashes are used by patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of symptoms of blepharitis: It will be evaluated through an 11 points analog visual scale (EVA), where zero (0) will represent the symptoms absence and ten (10) as the highest symptoms value. The instrument will be explained to the patients before its application. | — |
Countries
Colombia
Contacts
Public ContactGonzalo Nieto
Outcome results
None listed