Superficial benign skin lesions: seborrheic keratosis, common warts, benign dermic naevi, acrochordons (including fibroid pendulum), or isolated low-grade actinic keratosis Skin and Connective Tissue Diseases
Conditions
Interventions
This is a prospective unicentric open-label study to demonstrate the safety and clinical benefits of MDC-75 when applied to isolated low-grade actinic keratoses or benign superficial skin lesions such
Sponsors
R&D Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged at least 18 years old 2. Subjects with one or two clinically typical benign skin lesions among the following: seborrheic keratosis, common warts, benign dermic naevi, acrochordons (including fibroid pendulum), or subjects with isolated low-grade actinic keratosis 3. Subject of any phototype (according to Fitzpatrick scale) 4. Subject understanding and accepting the constraints of the CIP 5. Subject who has signed their informed consent for their participation in the study and a photograph authorization 6. Subject able to understand the language used in the investigational centre and the information given 7. Cooperative subject, aware of the necessity and duration of controls so that perfect adhesion to the CIP established by the investigational centre could be expected (able to comply with the CIP and follow CIP’s constraints and specific requirements) 8. Females of childbearing potential committing themselves to use an effective contraceptive method through the study and for at least 3 months before the inclusion visit (with no change during this period)
Exclusion criteria
Exclusion criteria: 1. Subjects with atypical skin lesions or skin lesions suspected to be a precancerous lesion or a skin cancer 2. Target lesion is a melanocytic epidermal nevus or any atypical nevi 3. Target lesion is a flat or mosaic-type wart 4 Target lesion located on a skin area affected by a chronic disease that might interfere with the evaluation or might be worsened by the test procedure (such as but not limited to atopic dermatitis, psoriasis, vitiligo) 5. Target lesion shows inflammation, ischemia or necrosis 6. Target lesion located on a skin area treated with a topical medication 7. Subject having a history of keloid, hypertrophic scar or any abnormal scarring 8. Subject with multiple post-inflammatory hyperpigmented lesions 9. Subject not willing to comply with the photoprotection measures related to the treated area 10. Subject who is pregnant or breastfeeding or considering a pregnancy during the study 11. Female subjects of childbearing potential with a positive urine pregnancy test at baseline 12. Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship 13. Subject who cannot be contacted by telephone in case of emergency 14. Subject in an exclusion period or participating in another biomedical research study (self-reported) 15. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation 16. Subjects working for the contract research organization (CIDP) in charge of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lesion size measured using vernier caliper on D0, D10, D20 and D35 or any other additional visits 2. Investigator global assessment (IGA) on a 5-point scale on D0, D10, D20 and D35 or any other additional visits 3. Global assessment of improvement on a 6-point scale on D35 4. Subject’s assessment of satisfaction on a 0 to 10 NRS on D35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Local tolerance and safety measured using 5-point scale at D0, D10, D20 and D35 or any other additional visits | — |
Countries
Mauritius
Contacts
Public ContactGitanjali Petkar
Outcome results
None listed