Clinical trial · Interventional
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
NCT02919735CI-TRIAL-00040019ELANcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II clinical trial
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CG 428 cutaneous solution | Drug | — | UNRESOLVED |
| Placebo cutaneous solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CG 428 cutaneous solution
- description
- Herbal Medicinal Product, topical use by spray on the scalp
- interventionNames
- Drug: CG 428 cutaneous solution
- type
- PLACEBO_COMPARATOR
- label
- Placebo cutaneous solution
- description
- Placebo, topical use by spray on the scalp
- interventionNames
- Drug: Placebo cutaneous solution
Primary outcomes (1)
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.