Clinical Trials
The clinical Trials
To comply with the medical device legislation, CS MEDICA has performed and completed preclinical studies and has several ongoing clinical trials on their broad range of products. Furthermore, CS MEDIA has two completed studies on CBD anti- hair Loss serum and CBD Psor+atopic lotion according to cosmetic regulations. Further, the Company has five planned studies. The studies are listed and summarized below.
COMPLETED CLINICAL TRIAL
Clinical study on hair serum
The study was performed under COVID-19 (18.12.2019-16.06.2020) where the STRESS LEVEL increased from 3.4 (before COVID-19) to 7.1 (during COVID-19) on a scale of 0-10. With stress being one of the main causes of hair loss, this study aimed to evaluate the hair growth efficacy of the products SAMPLE A002 (Hair Serum) VS B001 (Placebo) in a panel of [32] healthy human subjects after 141 days of daily use.
After 141 days of regular application (considering the period of COVID-19 global situation)
SAMPLE A002 (Hair Serum):
- was tested under dermatologist supervision,
- properties declared by the Sponsor have been confirmed based on a subjective questionnaire:
- 93 percent declared that the product reduces the amount of falling out hair
- 93 percent declared that the product provides an effective, clinically proven solution for the treatment of hair loss and baldness
- 100 percent declared that the product improves the general hair condition
- 87 percent declared that the product makes the scalp better condition
Properties declared by the Sponsor have been confirmed based on instrumental tests:
- statistically significant improvement of hair density (p-value = 0,00001 by 18 percent, on average.
- the best single, noticeable improvement was the increase of the average amount of hair per cm2 up to 36 percent.
- increases of hair density on the scalp (600 cm2) by 11 560,0 on average.
- the best single improvement of hair density on the scalp (600 cm2) by 18 800.
- statistically significant improvement of hair thickness (p-value = 0,00001) by 8 percent on average.
- the best single, noticeable improvement of hair thickness was the increase up to 14 percent.
The described study was conducted in the spirit of the Good Clinical Practice defined by the ICH Topic E6 “Note for Guidance and good clinical practice” (CPMP/ICH/135/95), the Helsinki Declaration (1964, WMA), and its successive updates.
Clinical study – Application Test- PSOR + Atopic Lotion
CANNSEN® CBD PSOR+ATOPIC Lotion’s efficacy has been tested in an external application test. The sample consisted of 60 people of both sexes aged from 22 to 72 with various types of skin. The lotion was applied twice a day for 28 days. The lotion is perceived by users as very good/good and
- Oils and moisturizes the skin – 92%*
- Eliminates skin dryness and tightness – 91%*
- Protects the skin against excessive dryness – 90%*
- Offers an effect of nourished/regenerated skin – 87%*
- Improves skin appearance and condition – 87%*
- Offers smoother/softer skin – 81%*
- Soothes skin irritations/reddening – 75%*
- Eliminates skin itching – 70%*
- Makes scales less visible – 66%
- None of the participants reported negative opinion about the product 95%*
*as reported by study participants
The lotion did not cause any allergy or irritation to any of the study participants, even in case of participants who have personal history of allergies. Thus, the study has concluded that the with irritation/allergy index of the lotion is equal to zero(0).
ONGOING CLINICAL TRIALS IN INDIA
(DELAYED DUE TO COVID-19)
Study NGA-01 gel (Arthritis gel)
A double-blinded, randomized, parallel-group study set-up with [60] healthy human subjects with Osteoarthritis with pain in joints (at the knee, hip, ankle, elbow, and shoulder) to evaluate efficacy and safety of NGA-01 gel against placebo in the treatment of Osteoarthritis with joint pain (for up to 60 days). To study the cooling effect and bone-strengthening activity of NGA-01 GEL.
Comparator: Placebo Gel
Route of Administration: Topical
Study Submission: Institutional Ethics Committee.
Study NGP-01 gel (Psoriasis gel)
A double-blinded, randomized, parallel-group study with [60] healthy human subjects with mild-to-moderate plaque psoriasis to evaluate efficacy and safety of NGP-01 gel against placebo in the treatment of mild to moderate Psoriasis (for up to. 90 days). The secondary objective is to study the reduction in redness and scaling of the skin.
Comparator: Placebo Gel
Route of Administration: Topical
Study Submission: Institutional Ethics Committee.
Study NGA-02 Capsules and Arthritis gel
A double-blinded, randomized, parallel-group study set-up with [60] healthy human subjects with Osteoarthritis with pain in joints (at the knee, hip, ankle, elbow, and shoulder) to evaluate efficacy and safety of NGA-02 Capsules and Arthritis gel against placebo (I.e. control group) in the treatment of Osteoarthritis with joint pain (approx. 60 days). To study the cooling effect and bone-strengthening activity of NGA-02 Arthritis capsules and Arthritis GEL.
Comparator: Placebo Capsules and Arthritis gel.
Route of Administration: Oral and Topical.
Study Submission: Institutional Ethics Committee.
Study NGP-02 Capsules and Psoriasis gel
A double-blinded, randomized, parallel-group study with [60] healthy human subjects with mild-to-moderate plaque psoriasis to evaluate efficacy and safety of NGP-02 Capsules and Psoriasis gel against placebo (i.e. control group) in the treatment of mild to moderate Psoriasis (approx. 90 days). The secondary objective is to study the reduction in redness and scaling of the skin.
Comparator: Placebo Capsules and Psoriasis Gel.
Route of Administration: Oral and Topical.
Study Submission: Institutional Ethics Committee.
PLANNED FUTURE CLINICAL TRIALS
The parameters are subject to variation.
Study NGW-01 Wound gel
A double-blinded, randomized, parallel-group study with [60] healthy human subjects with chronic wounds to evaluate efficacy and safety of NGW-01 gel against placebo in the treatment of wounds (approx. 90 days). The secondary objective is to study the reduction of wounds.
Comparator: Placebo Gel.
Route of Administration: Topical.
Study Submission: Institutional Ethics Committee.
Study NGPP-01 Pain Patch
A double-blinded, randomized, parallel-group study with [60] healthy human subjects with chronic pain to evaluate efficacy and safety of NGPP-01 patch against placebo in the treatment of pain (approx. 90 days). The secondary objective is to study the reduction of pain.
Comparator: Placebo Patch
Route of Administration: Topical
Study Submission: Institutional Ethics Committee.
Study NGPG–01 Protective nasal gel
A double-blinded, randomized, parallel-group study in a panel of [60] healthy human subjects to evaluate efficacy and safety of NGPG-01 gel against placebo in protection against pathogens before they enter the body (approx. 90 days). The secondary objective is to study the potential to prevent virus entry at the mucous membrane of the nose.
Comparator: Placebo Gel.
Route of Administration: Topical.
Study Submission: Institutional Ethics Committee.
Study NGPG-02 Capsules and Protective nasal gel
A double-blinded, randomized, parallel-group study with [60] healthy human subjects to evaluate efficacy and safety of NGPG-02 Capsules and Protective nasal gel against placebo capsules and Protective nasal gel in protection against pathogens before they enter the body (approx. 90 days). The secondary objective is to study the potential to prevent virus entry at the mucous membrane of the nose.
Comparator: Placebo Capsules and Protective nasal Gel.
Route of Administration: Nasal and Topical.
Study Submission: Institutional Ethics Committee.
Study NGS–01 Nasal spray Night
A double-blinded, randomized, parallel-group study with [60] healthy human subjects with a sleep disorder (e.g., insomnia, snoring) to evaluate efficacy and safety of NGS-01 spray against placebo in the treatment of insomnia and snoring (approx. 90 days). The secondary objective is to study the increased coherent sleep.
Comparator: Placebo Spray.
Route of Administration: Nasal.
Study Submission: Institutional Ethics Committee.
