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

• ClinicalTrials.gov Identifier: NCT02919735
• Recruitment Status: Completed
• First Posted: September 29, 2016
• Last Update Posted: August 13, 2019
• Sponsor: Legacy Healthcare SA
• Information provided by (Responsible Party): Legacy Healthcare SA

Tracking Information

• First Submitted Date: September 18, 2016
• First Posted Date: September 29, 2016
• Last Update Posted Date: August 13, 2019
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2017)

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.)

• Original Primary Outcome Measures (submitted: September 28, 2016): Rate of hair loss at different time points based on Olsen's Visual Analog Scale [ Time Frame: Every 3 weeks for 24 weeks. ]

Current Secondary Outcome Measures (submitted: August 30, 2017)

• 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. ]

Original Secondary Outcome Measures (submitted: September 28, 2016)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)
• 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
• Brief Summary: Phase II clinical trial
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Alopecia

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2018): 40
• Original Estimated Enrollment (submitted: September 28, 2016): 36
• Actual Study Completion Date: March 1, 2019
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02919735
• Other Study ID Numbers: ELAN
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Legacy Healthcare SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Legacy Healthcare SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Khalil KZ ZAMAN; Department Oncology - CHUV, 1011 Lausanne - CH

• PRS Account: Legacy Healthcare SA
• Verification Date: August 2019