Non inferiority study of a malathion 0.5% lotion versus reference therapy in the treatment of head lice: multicentre, randomised, investigator masked, parallel group.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2007-001844-34-FR
• Date of registration: 06/08/2007
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Dermo-Cosmétique
• Public title: Non inferiority study of a malathion 0.5% lotion versus reference therapy in the treatment of head lice: multicentre, randomised, investigator masked, parallel group.
• Scientific title: Non inferiority study of a malathion 0.5% lotion versus reference therapy in the treatment of head lice: multicentre, randomised, investigator masked, parallel group.
• Date of first enrolment: 26/11/2007
• Target sample size: 462
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001844-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Investigator masked; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Estonia, France, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Will be eligible patients who meet the following criteria:
- Patients aged 2 years or more,
- confirmed active head lice infestation, with at least 5 live lice of the half-head (adult lice and nymphs),
- patients accepting not to use any product in the same indication during the study period,
- parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study,
- negative urine pregnancy test at inclusion for woman of child bearing potential,
- use an efficient method of contraception (oral contraceptive, intra-uterine device, tubal ligature), for women of child bearing potential, for at least 2 months, during all the study and until 1 month after the end of the study,
- patient accepting to participate to the study and to give a written informed consent,
- able to understand the protocol and to come to the control visits, and comply with all trial requirements,
- registered with the a social security or health insurance system if required by law
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Will not be included patients who have one of the following criteria:

* Criteria related to the pathology:
- patients having only nits without live lice on the scalp,
- patient who has a history of a major medical/psychiatric illness or surgery which, in the judgement of the investigator, may interfere with study medication, metabolism and/or study implementation and/or study parameter assessment(s).

* Criteria related to treatments:
- patient with a history of hypersensitivity to head lice product or at least to one ingredient in the inclusion visit,
- patient using a pediculicidal and/or an ovicidal product within the month prior to entering the study,
- patient who has received an Ivermectine treatment within the month prior the inclusion visit,
- patient who has received oral or parenteral trimethoprim/sulfamethoxazol within the month prior the inclusion visit,
- patient using regularly a medical and/or cosmetic topical product on the scalp.

* Criteria related to the population:
- female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
- participation to an other clinical trial in the previous month before the inclusion visit or during the study,
- patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

the patient who will be included in this clinical trial present a confirmed active head lice infestation.

Intervention(s)

Product Name: Malathion 0.5%
Product Code: V3777 A
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Malathion
Current Sponsor code: V3777A
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 0.50 Grammes-

Trade Name: Prioderm®
Product Name: Prioderm®
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Malathion
CAS Number: 121-75-5
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 0.55 Grammes-

Primary Outcome(s)

Secondary Objective: the secondary objectives are:
- To assess the head lice infestation, 2 days after one single application of the lotion,
- To assess the local and general tolerability of the lotions,
- To assess the cosmetic acceptability of the two lotions.

Primary end point(s): Primary criterion for the Efficacy:
- cure rate of head lice 12 days after one single application of the lotion, this criterion will be assessed by the rate of patients without live lice on day 12 (D12).

Main Objective: The main objective is to assess the non inferiority of malathion 0.5% lotion (V3777 A) versus Prioderm® lotion (0.5% Malathion), in the cure of the head lice 12 days after one single application. The cure is defined by the absence of live lice.

Secondary ID(s)

V03777 LE 301A

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 24/11/2018
• Date Completed: 02/11/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001844-34/results