Study to assess whether nacystelyn combined with isotretinoin is efficacious, safe and tolerable for the treatment of difficult to cure common acne.

Phase 1

• Conditions: Recalcitrant acne vulgaris; MedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-005270-10-BG
• Lead Sponsor: ABORATOIRES SMB S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-14
• Study Completion: 2022-09-01
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients must satisfy the following criteria before entering the study:
1.Males or females, aged between 12 and 50 years, inclusively.
2.Patients presenting a severe recalcitrant acne vulgaris with 10 or more inflammatory nodules with a diameter of 5 mm or greater (facial and/or truncal).
3.Weight between 40 – 110 kg.
4.Able to comply with all study procedures.
5.Patients who are willing and able to provide written informed consent, after being informed of all the pertinent aspects of the study.
If the patient is female and of childbearing potential, she must be using two separate and efficient means of birth control. (See contraception and pregnancy tests section for more details). Contraception should be used for at least 1 month prior to starting treatments, throughout treatments and continue for at least 1 month after stopping treatments. A negative pregnancy test must be provided at screening and within 11 days prior to initiating therapy or the day of the randomisation at the latest. Even female patients who normally do not employ contraception due to a history of infertility, amenorrhea or claim absence of sexual activity will have to use contraception while taking the study treatments

Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participating in the study:
1.Evidence of any clinically significant immunological, neoplastic, endocrine, hematological, gastrointestinal, neurological, cardiovascular, or psychiatric abnormalities.
2.Abnormal liver function (hepatocellular insufficiency, chronic or active liver disease, biliary tract disease, sustained elevation of serum liver enzymes (simultaneously ASAT and ALAT > 2x UNL)).
3.Abnormal renal function (clearance of creatinine < 50 mL/min and creatinemia > 20 mg/L) or any renal disease likely to lead to renal dysfunctions.
4.No clinically significant abnormal laboratory value and/or vital signs measurement as per the judgement of the study investigator.
5.Patients with any sensitivity or allergy to any of the products used within this clinical trial: known hypersensitivity to isotretinoin, retinoic acid and derivatives of vitamin A.
6.Any skin disease that might interfere with the evaluation of severe recalcitrant nodular acne.
7.Patients with a history or current psychiatric illness (e.g. depression, psychotic symptoms, suicidal behavior).
8.Patients who, during the past month, have received systemic corticosteroids and during the past 7 days have received topical corticosteroids. For isotretinoin 6 months wash out period should be fulfilled.
9.Recent history of alcoholism (above 21 beverages per week. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer) or drug abuse.
10.Use of any prohibited medication as detailed in the concomitant medication section of the protocol.
11.Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing.
12.Donation of blood during the study and for one month after discontinuation of study treatment.
13.Pregnant and breastfeeding women
14.Subjects who were unlikely to co-operate with the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified