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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 : Completed
First Posted : September 29, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Legacy Healthcare SA

September 18, 2016
September 29, 2016
August 17, 2018
October 2016
July 2018   (Final data collection date for primary outcome measure)
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.)
Rate of hair loss at different time points based on Olsen's Visual Analog Scale [ Time Frame: Every 3 weeks for 24 weeks. ]
Complete list of historical versions of study NCT02919735 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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)
  • 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.
  • 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 ]
  • Patient's subjective assessment through questionnaire [ Time Frame: Every 3 weeks for 24 weeks. ]
  • 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)
  • Time to reach grade 2 alopecia during chemotherapy 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)
  • 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)
  • Percent of hair loss according to Olsen's visual analog scale (OVAS) at different time points after the end of the chemotherapy [ Time Frame: Every 3 weeks for 24 weeks. ]
    Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.
  • Adverse events based on the CTCAE 4.03. [ Time Frame: Every 3 weeks for 24 weeks. ]
  • Patient's subjective assessment through questionnaire [ Time Frame: Every 3 weeks for 24 weeks. ]
    Quality of life, efficacy and tolerance questionnaires developed by the investigator
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)
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
Phase II clinical trial
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Alopecia
  • 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
  • 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
  • Experimental: CG 428 cutaneous solution
    Herbal Medicinal Product, topical use by spray on the scalp
    Intervention: Drug: CG 428 cutaneous solution
  • Placebo Comparator: Placebo cutaneous solution
    Placebo, topical use by spray on the scalp
    Intervention: Drug: Placebo cutaneous solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
36
August 6, 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT02919735
ELAN
Yes
Not Provided
Plan to Share IPD: Yes
Legacy Healthcare SA
Legacy Healthcare SA
Not Provided
Principal Investigator: Khalil KZ ZAMAN Department Oncology - CHUV, 1011 Lausanne - CH
Legacy Healthcare SA
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP