E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The two severe dandruff conditions to be investigated in this study are pityriasis capitis and seborrhoeic dermatitis. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011859 |
E.1.2 | Term | Dandruff |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039794 |
E.1.2 | Term | Seborrhoeic dermatitis capitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to find out if an antifungal shampoo is an effective treatment for the severe dandruff conditions pityriasis capitis and seborrhoeic dermatitis when used twice weekly in a study centre setting. The safety aspects of using the shampoo will also be investigated. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to find out if the study shampoo can induce an improvement in scalp erythema (redness and inflammation), as well as find out the patients' opinion as to whether the shampoo is effective in treating their symptoms of itching and flaking skin, which are associated with severe dandruff conditions. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for inclusion into the washout period, the patient must: i)be 14 years of age or older. ii)have a history of severe dandruff for a minimum of the last two months. iii)have an overall dandruff severity score (ODSS) of 35 or more (out of a maximum of 80). iv)be prepared to attend the clinic twice a week for a total of 7 weeks (14 visits in total). v)be prepared to have their hair washed by a technician at each study centre visit. vi)be willing to wash their hair only with their allocated Johnson's Baby shampoo at home, for the entire study period. vii)not tint, perm or colour their hair during the study period. viii)not commence use of any new conditioner or styling products that they do not use normally. ix)not have their hair styled in such a way as to prevent scalp assessment.
After washout, to be eligible for recruitment into the treatment period: i)The patient’s overall dandruff severity score must still a minimum of 35 (out of a maximum of 80). |
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E.4 | Principal exclusion criteria |
i) Patients who usually wash their hair less than twice weekly. ii)Patients with hair that is considered by the Investigator to be difficult to part readily for the purpose of scalp assessments (e.g. dreadlocks, braids, cornrows etc). iii) Patients with a history of intolerance or skin sensitivity to any of the ingredients of the study shampoos (treatment shampoos or Johnson's Baby Shampoo). iv) Patients who have applied topical corticosteroids to their scalp condition within the 4 weeks prior to study entry. v) Patients who have taken systemic treatment for any dermatosis within the previous 2 weeks prior to study entry. vi) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial. vii) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. viii) Patients who have psoriasis, discoid lupus erythematosus or lichen simplex chronicus, or who are immunocompromised. ix) Female patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). x) Patients considered unable or unlikely to attend the necessary follow-up visits. xi) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be the improvement from baseline (end of washout period) in the overall dandruff severity score (ODSS) after 4 weeks of treatment, based on the flaking and scaliness, as measured by the Investigator. This method of assessment is consistent with published studies investigating shampoos for the treatment of pityriasis capitis and seborrhoeic dermatitis.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
ODSS will be measured at the start of treatment and after 4 weeks of treatment. |
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E.5.2 | Secondary end point(s) |
1. Investigator assessment of erythema The erythema secondary efficacy parameter will be the improvement from baseline (end of washout period) in the severity of erythema after 4 weeks of treatment, as scored by the Investigator. As for the overall dandruff severity score, the severity of erythema will be assessed by the Investigator before the study centre hair wash is performed, and will take place under controlled lighting conditions. The severity of erythema will be assessed by the investigator at the start of the treatment period, and after 2 and 4 weeks of treatment, using the 5 point scoring system below: 0=clear, 1=mild (faint erythema), 2=moderate (definite erythema), 3=severe (definite erythema with some inflammation), 4=very severe (definite erythema with severe inflammation)
2. Patients’ self-assessed improvement in dandruff severity after 4 weeks of treatment All patients will be asked their own impressions of their condition at the 2 and 4 week visits compared to the start of the treatment period (i.e. end of washout), in terms of dandruff severity, using the following scale: 0=completely cleared, 1=almost cleared, 2=significant improvement 3=some improvement, 4=no difference, 5=some deterioration 6=significant deterioration, 7=considerably worsened condition The percentage of patients with self-assessed dandruff severity improvement score of 2 (=significant improvement), 1 (=almost cleared) and 0 (=completely cleared) after 4 weeks of treatment will be the self-assessed severity secondary outcome.
3. Improvement in patients’ self-assessed pruritus after 4 weeks of treatment At recruitment, 2 weeks and 4 weeks, patients will be asked to score how itchy their scalp feels at present, on a scale of 0-4 as follows: 0=no itching, 1=mild irritation, 2=some itching, some urge to scratch, 3=considerable itching, hard to resist scratching, 4=extremely itchy, uncontrollable urge to scratch at all times. The percentage of patients with an improved self-assessed pruritus score after 4 weeks of treatment compared to baseline (end of washout period) will be the patient assessed pruritus secondary outcome.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Investigator assessment of erythema at baseline and after 2 and 4 weeks of treatment 2. Patient self-assessment of improvement in dandruff severity after 2 and 4 weeks of treatment 3. Patient self-assessment of itching at baseline and after 2 and 4 weeks of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |