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Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN) (ELAN)

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ClinicalTrials.gov Identifier: NCT02919735
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Legacy Healthcare SA

Brief Summary:
Phase II clinical trial

Condition or disease Intervention/treatment Phase
Alopecia Drug: CG 428 cutaneous solution Drug: Placebo cutaneous solution Phase 2

Detailed Description:
The aim of this trial is to compare the degree of efficacy, safety and tolerability of CG 428 cutaneous solution versus placebo on prevention of chemotherapy induced alopecia (CIA) in female patients with metastatic cancer treated with selected regimens inducing alopecia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : October 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: CG 428 cutaneous solution
Herbal Medicinal Product, topical use by spray on the scalp
Drug: CG 428 cutaneous solution
The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours

Placebo Comparator: Placebo cutaneous solution
Placebo, topical use by spray on the scalp
Drug: Placebo cutaneous solution
The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours




Primary Outcome Measures :
  1. 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) [ Time Frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment ]
    Physical examination of the scalp: skin AEs, hair status (alopecia graded according to CTCAE v.4.03.)


Secondary Outcome Measures :
  1. Rate of grade 2 alopecia according to CTCAE v. 4.03. [ Time Frame: Every 3 weeks for 24 weeks. ]
    CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

  2. Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. . [ Time Frame: Every 3 weeks for 24 weeks. ]
    CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

  3. Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy [ Time Frame: Every 3 weeks for 24 weeks. ]
    CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

  4. Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy. [ Time Frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment ]
    Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.

  5. Adverse events based on the CTCAE 4.03. [ Time Frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment ]
  6. Patient's subjective assessment through questionnaire [ Time Frame: Every 3 weeks for 24 weeks. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919735


Contacts
Contact: Khalil KZ ZAMAN, PhD +41 79 556 78 01 khalil.zaman@chuv.ch
Contact: Nicole NJ JAMES FARESSE, PhD +41 21 314 33 69 Nicole.James-Faresse@chuv.ch

Locations
Switzerland
CHUV Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Khalil KZ ZAMAN, PhD    +41795567801    khalil.zaman@chuv.ch   
Contact: Nicole NJ JAMES FARESSE, PhD    +41213143369    Nicole.James-Faresse@chuv.ch   
Sponsors and Collaborators
Legacy Healthcare SA
Investigators
Principal Investigator: Khalil KZ ZAMAN Department Oncology - CHUV, 1011 Lausanne - CH

Responsible Party: Legacy Healthcare SA
ClinicalTrials.gov Identifier: NCT02919735     History of Changes
Other Study ID Numbers: ELAN
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Legacy Healthcare SA:
Alopecia
Hair
Chemotherapy
Cancer

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions