EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional

Summary: 
      This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy
      induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center,
      randomized, controlled trial in breast cancer survivors.

      Hair condition and parameters of 61 breast cancer survivors who were previously included in
      DERMA study (a prospective cohort study to assess appearance changes due to breast cancer
      treatment completed in July, 13th,2013) will be assessed.

        1. Patients whose hair parameters are below the baseline as measured before the start of
           the chemotherapy or

        2. who complain from incomplete hair regrowth will be eligible to participate in the
           randomized controlled trial.

      Patients who agree to participant in the study will be randomly assigned to two parallel arms
      (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo
      twice per day (morning, evening) for 6 months, for the efficacy assessment.

      Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using
      Folliscope 4.0.

      Secondary endpoints included hair density at 6 months after intervention, distress due to
      chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair
      quality improvement, body image and quality of life, and time to first visible improvement
      based on global photographs of hair and nails.
    

Detailed description: 
      The research team at Cancer Education Center at Samsung Comprehensive Cancer Center has
      studied CIA and its impact on distress and psychosocial well-being since 2008. We found that
      more than half of the breast cancer patients experienced higher distress due to CIA, during
      cancer treatment, and this distress was strongly associated with negative body image, overall
      health status, and psychosocial well-being. In a recent prospective cohort study, we assessed
      skin and hair change patterns before, during and 6 months after chemotherapy in 61
      volunteers. We found that the majority of the patients still experienced CIA at 6 months
      after completion of chemotherapy. Actually, hair diameter at 6th month after chemotherapy had
      not recovered to baseline level. Permanent chemotherapy-induced alopecia, defined as absent
      or incomplete hair regrowth at ≥6 months post-chemotherapy, was reported from 53 to 74%. Like
      CIA, permanent CIA also lacks recognition and has been underserved regardless of patients'
      needs. The first botanical blend Legacy Healthcare developed and patented is Cellium. Cellium
      is composed of 4 botanicals (Allium cepa L., Citrus limon L., Theobroma cacao L., Paullinia
      cupana). The first product derived from Cellium is a topical lotion for male and female
      alopecia, CG210. Based on the safety and efficacy data, the EMA (European Medicines Agency)
      has considered CG210 eligible for a European centralized herbal medicine registration. CG428
      is the second product derived from Cellium. CG428 contains the exact same ingredients as
      CG210, in a different dosage. Legacy Healthcare have conducted a pilot studies with CG428 in
      Japan. The trial included female cancer survivors experiencing permanent/persistent CIA for
      more than 12. Based on the results, several cancer treatment centers in Japan have started to
      recommend the product on a compassionate basis.We therefore hypothesize that the investigated
      topical lotion may mitigate the impact of protracted or permanent CIA in cancer survivors by
      restoring a normalized apoptotic process of hair follicular cells and reducing the acute, as
      well as chronic inflammation in the scalp, two issues that may remain unsettled following
      anticancer treatment.
    

Intervention name(s): CG428; Placebo
Intervention type(s): Other; Other
Intervention description(s): The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.; The placebo group will received placebo which excluded active ingredients. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care