Efficacy and safety comparison of a plant essential oil formulation vs traditional shampoo for Demodex ophthalmic infection treatment

• Register: ISRCTN
• Last refreshed on: 19 December 2016
• Main ID: ISRCTN63299516
• Date of registration: 30/04/2015
• Prospective Registration: Yes
• Primary sponsor: Laboratorios procaps S.A.
• Public title: Efficacy and safety comparison of a plant essential oil formulation vs traditional shampoo for Demodex ophthalmic infection treatment
• Scientific title: Production and evaluation of a formulation for prevention and treatment of blepharitis and keratoconjunctivitis caused by the ectoparasite Demodex Sp
• Date of first enrolment: 04/05/2015
• Target sample size: 158
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN63299516
• Study type: Interventional
• Study design: Double blind interventional open randomized controlled trial (Treatment)

Countries of recruitment

Colombia

Contacts

• Name: Martha Lizarazo

• Name: Gonzalo Nieto

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Demodex folliculorum
Infections and Infestations
Demodex folliculorum

Intervention(s)

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 to the assigned intervention to the patient because the treatment will be masked to the ophthalmologist who applied; 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 affected patients will be subjected in ophthalmologic clinic according to the modified rubbing technique. Prior to the application of treatment, gauzes impregnated with saline solution at 39 °C will be applied in closed eyes for five minutes, in order to cause dilation of the hair follicles of the eyelashes to allow greater penetration of the product being applied.
The topical local anesthetic Alcaine® 0.5% will be administered in each eye, at the rate of one drop per eye, and an eye plastic protector shall be placed in each eye, for protecting the eye during the procedure. A moistened gauze with placebo or the intervention will be used for rubbing the roots of the lashes with a rapid movement from one end to the other of the eyelid, at a constant pressure that causes the removal of deposited debris on the base of the eyelashes. Once the gauze meets debris, this one will be changed. This procedure will be repeated until no debris gauze, which usually occurs after 4 applications for each eyelid (upper and lower).
The time between changes of the gauzes is minimal, so the procedure may be considered as continuous. When there is no debris in the gauze, the procedure will be finished.
The procedure will be performed every four days using a protocol that will try to control all the stages of the parasite cycle and a total duration of 6.2 weeks
2. Associated interventions:
In both groups the recommendations of the ophthalmologist includes:
2.1. Wash sheets and pillow

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Laboratorios Procaps S.A