Brief description of trial (Data source: BASEC)
Les patientes seront randomisées dans 2 bras de traitement (18 patientes par bras). La solution cutanée CG 428 (ou placebo) sera appliquée deux fois par jour dans les 10 jours précédant le début de la chimiothérapie, puis, le traitement sera interrompu quand le PI observera une alopécie de grade 2 chez la patiente traitée. L'application du produit sera reprise 3 semaines avant la fin de la chimiothérapie ou jusqu'au début d'un autre traitement alopéciant. Le traitement avec la solution cutanée peut également être interrompu si nécessaire à tout moment pour des raisons médicales ou si la patientes le souhaite.
Health conditions investigated(Data source: BASEC)
Alopécie induite par la chimiothérapie
Health conditions
(Data source: WHO)
Alopecia
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Solution cutanée CG 428
Interventions
(Data source: WHO)
Drug: CG 428 cutaneous solution;Drug: Placebo cutaneous solution
Criteria for participation in trial
(Data source: BASEC)
- patientes présentant un cancer nécessitant une chimiothérapie pré-spécifiée
- espérance de vie ≥ 6 mois
Exclusion criteria
(Data source: BASEC)
- autre traitement anticancéreux ayant un impact sur la chute des cheveux
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Adult female, age = 18 years.
- Patient with cancer, requiring one of the following pre-specified chemotherapy regimen
according to local guidelines: weekly paclitaxel, weekly docetaxel, eribuline or
associationof weekly paclitaxel/docetaxel with carboplatine (association of targeted
therapies not influencing significantly the risk of alopecia is allowed, i.e.
trastuzumab, pertuzumab or bevacizumab).
- Healthy hair (no current alopecia or scalp disease treatment).
- Life expectancy = 6 months.
- Able to use the study treatment in compliance with the protocol.
- Physical and psychological ability to participate.
- Negative serum pregnancy test within 14 days prior to randomization in premenopausal
women with childbearing potential.
- Patients must agree to not shave their head (minimum = 1 cm).
- Signed and dated informed consent.
Exclusion Criteria:
- Other ongoing anti-neoplastic therapy or other investigational drug with potential
effect on hair growth.
- Patients treated with proteasome inhibitors, i.e. bortezomib.
- Prior radiotherapy to the scalp with residual alopecia.
- Known allergy or hypersensitivity to some components of CG 428 cutaneous solution
(including allium cepa (onion), citrus, caffeine, theobromine).
- Pre-existing alopecia or significant scalp disease, which may alter study treatment
administration or absorption.
- Concomitant use of cold cap or any other anti-hair loss treatment.
- Hair transplants.
-
Further information on trial
Date trial registered
Sep 18, 2016
Incorporation of the first participant
Oct 1, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
A Randomized, Double Blind, Single Center, Controlled Study to Compare the Efficacy, Safety and Tolerability of CG 428 Cutaneous Solution With Placebo on Alopecia in Cancer Female Patients Under Chemotherapy
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Rate of hair loss at different time points based of on Olsen's Visual Analog Scale (OVAS) and using the Severity of Alopecia Tool score (SALT score)
Secundary end point
(Data source: WHO)
Patient's subjective assessment through questionnaire;Adverse events based on the CTCAE 4.03.;Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.;Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy;Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .;Rate of grade 2 alopecia according to CTCAE v. 4.03.
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
Yes
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr Khalil Zaman
+41 79 556 78 01
khalil.zaman@chuv.ch
Contact for general information
(Data source: WHO)
Khalil KZ ZAMAN
Department Oncology - CHUV, 1011 Lausanne - CH
Contact for scientific information
(Data source: WHO)
Khalil KZ ZAMAN
Department Oncology - CHUV, 1011 Lausanne - CH
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
15.06.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00385
Secondary ID (Data source: WHO)
ELAN
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