Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT01804335
Eligibility Criteria:
Inclusion Criteria:
1. The Subject is a male or female, who is at least 18 years of age at Screening visit.
2. The Subject has a clinical diagnosis of stable CTCL early stage (IA-IIA). The subject has :a) A known stable TNMB stage (cancer classification based on analysis of Tumors, Nodes, Metastasis and Blood), or b) Stable patch or plaque lesions that have not responded to topical treatment with corticosteroids or nitrogen mustard or which have relapsed after prior therapy.
3. The Subject presents at least 3 distinct lesions (one selected as index lesion, one dedicated to biopsy and another one dedicated to tape-stripping).
4. If the Subject is a female of childbearing potential, she agrees to use a highly contraceptive method for the duration of the study and for one month after the last product application. A highly effective method of contraception is defined by: 1) Bilateral tubal ligation 2) Combined oral contraceptives (estrogen and progesterone) implanted or injectable contraceptives, on a stable dose for at least 1 month prior to screening visit, 3) Hormonal intra-uterine device (IUD), inserted at least one month prior to the Screening visit.
5. If the Subject is female of childbearing potential, she has at Screening (at least 14 days before Baseline) and at Baseline a negative result for urine pregnancy test (UPT)having a sensitivity down to at least 25 Ul/ml for human chorionic gonadotrophin (hCG).
6. If the Subject is a female of non-childbearing potential, she has to be postmenopausal (absence of menstrual bleeding for at least one year and without any other medical reason), or presenting with a hysterectomy or a bilateral ovariectomy.
7. The Subject is willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
8. The Subject has understood and signed an Informed Consent Form (ICF) at Screening, prior to an investigational procedures being performed.
9. The Subject is apprised of the Health Insurance Portability and Accountability Act (HIPAA), and is willing to share personal information and data, as verified by signing a written authorization at the screening.
Exclusion Criteria:
1. The subject has any uncontrolled or serious disease (other than CTCL), or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
2. The subject has known or suspected allergies or sensitivities to any components of the study drug (see Investigator's Brochure).
3. The subject, if female, has a positive urinary pregnancy test, is breast-feeding or is planning a pregnancy during the course of the study.
4. If the subject needs a relative to apply the study product, the relative is a female who is pregnant, lactating or intends to conceive during the clinical study or within 1 month after the last product application.
5. The subject is in an exclusion period from a previous clinical study, takes part into any other clinical trial of a drug or device, OR participated within 1 month prior to baseline.
6. The subject has used any of the following treatments or procedure before the first study treatment application (Baseline) within the wash-out periods defined below: corticoids or Aldera (imiquimod) 4 weeks; retinoids, nitrogen mustard (mechlorethamine), Carmustine (BCNU), or phototherapies 2 weeks, any systemic treatment dedicated to CTCL within 4 weeks.
7. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
8. The subject has an abnormal ECG judged clinically significant by the investigator and/or PR interval outside the range of 120 ms to 220 ms, QRS\>120 ms, and corrected QT interval (QTc)\>450 ms.
9. The subject presents seropositivity for hepatitis B surface antigen(HBsAG), hepatitis C virus (HCV) antibody and /or human immunodeficiency virus (HIV) 1 and 2 antibody.
10. The subject is vulnerable (such as deprived of freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01804335
Study Brief:
Protocol Section:
NCT01804335