A Phase 2 interventional study of CG 428 cutaneous solution and Placebo cutaneous solution in Alopecia, sponsored by Legacy Healthcare SA. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Legacy Healthcare SA · Phase 2, Interventional, and Supportive care
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Legacy Healthcare SA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Herbal Medicinal Product, topical use by spray on the scalp
Drug: CG 428 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
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
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)
Physical examination of the scalp: skin AEs, hair status (alopecia graded according to CTCAE v.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
Rate of grade 2 alopecia according to CTCAE v. 4.03.
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.
Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.
Time frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
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.
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Legacy Healthcare SA