Chemotherapy induced alopecia in women
Conditions
Interventions
Trade Name: Alpicort F
Product Name: Alpicort F
Product Code: n.a.
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Estradiol (INN) benzoate
Other descriptive name: Estradiolbenzoate
Conce
Sponsors
Dr. August Wolff GmbH & Co KG Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: • 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. ;Primary end point(s): none | — |
Countries
Germany
Outcome results
None listed