E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chemotherapy induced alopecia in women |
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MedDRA Classification |
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 |
To compare the hair density from visit V3 (2 weeks after end of chemother-apy) until study end (10 weeks after the end of chemotherapy) between Alpicort F® and placebo using the baseline adjusted AUC of the no. of hairs/cm2 adjusted for the hair density before start of chemotherapy. |
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E.2.2 | Secondary objectives of the trial |
• Determination of the time, hair density (hairs/cm2) has reached 75% of baseline value. • To compare the no. of hairs/cm2 at every visit between Alpicort F® and placebo. • To compare the anagen- and telogen ratio (%) as well as the anagen- and telogen hair density (n/ cm2) at every visit between Alpicort F® and placebo. • To compare the vellus- and terminal hair ratio (%) as well as the vellus- and terminal hair density (n/ cm2) at every visit between Alpicort F® and placebo. • To compare the optical appearance of the capillus at every visit between Alpicort F® and placebo. • To compare the hair loss activity (pull test) at every visit between Alpi cort F® and placebo. • To compare the alopecia area clinically/optically (semi quantitative; standardized planimetrical evaluation) at every visit between Alpicort F® and placebo. • To compare the results of the subjective patient questionnaire (regar- ding hair loss) at every visit between Alpicort F® and placebo.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The investigator must ensure that the patients meet all of the following inclusion criteria at the screening visit: • Provision of written informed consent at the screening visit • Patients must be female • Patients must be aged ≥18 to 65 years • Either childbearing potential terminated by surgery, or a negative urine pregnancy test dur-ing screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception. An acceptable method of birth control is a combination of hormonal contraception or intra-uterine device with a barrier method (e.g. male or female condoms, diaphragms) or same sex relationship. Non-childbearing potential includes being surgically sterilized or postmeno-pausal with no menstrual bleeding for at least one year prior to the study. Participants and their respective partners have to be sterilized or postmenopausal to not need any birth con-trol method. • Patient must have either ovarian cancer or bronchial cancer • Planned chemotherapy, either acc. to the standards of the ‘Klinik für Frauenheilkunde’ (Carboplatin + Taxol), or acc. to the standards of the ‘Medizinische Klinik III (Pneumologie)’ (Cis-/Carboplatin + Etoposid or Cis-/Carboplatin + Vinorelbine) • Patients must have an ECOG/WHO performance status of 0 or 1 (0 = fully active, able to carry out all normal activity without restriction; 1 = restricted in physically strenuous activity but ambulatory….) • Life expectancy of at least 1 year
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E.4 | Principal exclusion criteria |
Patients meeting any of the criteria listed below will not be included in the study: Medical Reasons • Presence of a concomitant malignant disease (other than ovarian or bronchial cancer) • Second malignancy in history ≤ 2 years before study start • Presence of other non-malignant systemic diseases which may prevent prolonged follow-up • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment • Known hypersensitivity to any components of the study medication: Prednisolone, Salicylic acid, Estradiolbenzoate, Propylenglycol, Arginine, 2-Propanol • Suspected estrogen dependent tumours • Unexplained haemorrhage from the genitals • Administration of the study medication on mucous membranes, in the mouth, in or at the eye, at the genital area, or internally • Concomitant varicella, tuberculosis, lues, or inflammable vaccination reactions • Mycosis or bacterial cutaneous infections • Perioral dermatitis or rosazea • Weeping or acute scalp diseases • Endometriosis or mastopathy • Concomitant administration of estrogens, androgens, thyroid depressants, thyroid hor-mones, phenytoin, carbamazepin, valproic acid, retinoids, interferon, heparin, ACE-inhibitors, allopurinol, permanent NSAIDs, tranquilizers • Pregnancy or breast feeding • Diffuse alopecia • Alopecia areata • Inflammable alopecias • Psoriasis • Eczemas • Iron deficiency • Auto-immune diseases • Hypo- or hyperthyreosis • Radiotherapy of the neurocranium
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.3 |
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.8.5 | 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 | Information not present in EudraCT |
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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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |