Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: Hydrozid Spray: Hydrozid is applied to a lesion directly from the canister. Hydrozid should be applied from a distance of 2 to 3 cm and for 2 to 6 seconds, depending upon the location o
Sponsors
BIBAWO Medical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patientsof age between 18 to 65 years both inclusive. 2. Patient has atleast one or more epidermal or dermal skin lesions (e.g., Verruca plantaris, Verruca vulgaris, Verruca plana, Keratosis seborrhoica, Lentigo (facial), Lentigo (non-facial), Acrochordon (skin tag),), Keratosis actinica (facial), Keratosis actinica (non-facial) Molluscum contagiosum )lesions of diameter b�ªtween â�¥ 5 mm and â�¤ 10 mm in an area suitable for treatment. 3. Patient is willing to have digital photographs taken of the treatment area and agrees to use ofphotographs for presentation, educational, or marketing purposes. 4. Patients who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin colour, in the area of intended treatment in the previous 1 month (e.g., hydroquinone, corticosteroids, laser surgery) 2. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period 3. Open wounds, cuts and delicate or eczematous skin,Scars or tattoos in the location of the treatment sites 4. History of melanoma. 5. Known history of illness or adverse reaction to cold insult (e.g..cryoglobulinaemia, Raynaudââ?¬•s disease, cold urticaria, blood dyscrasias, or uncertain diagnosis). 6. Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism. 7. Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months. 8. Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases. 9. Patient has a history of sensitivity to any of the ingredients in the study medications. 10. Patients who cannot tolerate cryotherapy for their own reasons. 11. Patient has any current skin disease (e.g., Psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator,might put the Patient at undue risk by study participation or interfere with the study conduct or evaluations. 12. Inability or unwillingness to comply with the study requirements. 13. Female Patients who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. 14. History of alcohol abuse and smoking. 15. Current enrollment in a clinical study of any other unapproved investigational drug or device within 30 days prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The incidence of adverse events (AEs) and severe adverse events (SAEs), considered as related to the study treatment. 2.Assessment of local skin reactions (LSRs) 3.Pain assessment by VAS scale just after therapy, 2 hrs, 4 hrs, 8 hrs and 24hrs after treatment. 4.Incidence rate of pigmentation and scarring following study treatment as assessed by Vancouver Scar Scale.Timepoint: 1.60Ã?±2 Days 2.60Ã?±2 Days 3.24 Hours 4.60Ã?±2 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with total disappearance of skin lesions at the end of study visitTimepoint: 60Ã?±2 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed