AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (LEAP)
- Conditions
- Moderate acne vulgaris with acne-induced post-inflammatory hyperpigmentation (PIH)MedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-003608-41-ES
- Lead Sponsor
- Galderma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Male or female subject of any ethnic background of at least 13-35 years old,
2. Subject with clinical diagnosis of acne vulgaris and PIH, defined by:
a) moderate acne on the face (acne IGA=3);
b) with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose);
c) moderate to marked PIH on the face (ODS hyperpigmentation scale 4-6);
d) No more than one acne nodule or cyst (> 1 cm) on face (excluding the nose),
3. Subject with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST),
4. Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit (Visit 2),
5. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study. This criterion also applies to a prepubertal female subject who begins menses during the study.
Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below:
-Progestogen-only oral hormonal contraception
-Combination of male condom with cap, diaphragm, or sponge with
spermicide (double barrier methods) (*In Germany only, double barrier methods are not considered an adequate and approved method of
contraception).
Note: double barrier methods” refers to simultaneous use of a physical
barrier by each partner. Use of a single barrier method (e.g. condom)
together with a spermicide is not acceptable.
-Combined (estrogen-and progestogen-containing) oral, intravaginal, or
transdermal hormonal contraception
-Injectable or implanted hormonal contraception
-Intrauterine devices or intrauterine hormone-releasing system
-Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study
-Bilateral vasectomy of partner at least 3 months before the study
6. Female subjects of non-childbearing potential, e.g.: premenses, post-menopausal (absence of menstrual bleeding for 1 year prior to Baseline, without any other medical reason), hysterectomy, bilateral salpingectomy, or bilateral oophorectomy,
7. Subject having read, understood and signed the approved Informed Consent Form (ICF) prior to any participation in the clinical trial. Subject under the age of 18 having signed an assent form to participate in the clinical trial and their parent(s) or legal representative having read and signed the informed consent form prior to any clinical trial related procedures, samples and photos are collected,
8. Apprised of the Health Insurance Portability and Accountability Act (HIPAA), if in the US and is willing to share personal information and data, as verified by signing a written authorization at the screening visit.
9. Subject willing and able to comply with the requirements of the trial protocol.
Subject must adhere to the visit schedule, concomitant therapy prohibitions, and
must be compliant to the treatment. (for subjects who are minors, the parent(s)/legal representative must be also willing and able to help the subject comply with study requirements).
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1
1. Subject with severe acne (IGA > 3),
2. Subject with more than 1 nodule/cyst on the face (excluding the nose),
3. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulocystic acne, acne requiring systemic treatment,
4. Subject with damaged facial skin (e.g., tattoo, skin abrasion, eczema or sunburned skin) that may interfere with study assessments,
5. Female subject who is pregnant, lactating or planning a pregnancy during the study,
6. Female subject of childbearing potential using combined oral contraceptives approved as acne treatments (e.g., Ortho Tri-Cyclen®, Yaz®, Diane-35®), in whom the dose has not been stable for at least 6 months prior to the Baseline visit,
7. Subject with known impaired hepatic or renal functions,
8. Subject with a wash-out period for topical treatment or procedures on the face less than:
-Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, other anti-inflammatory drugs or other acne treatments (for example salicylic acid treatments/ transdermal contraceptives are forbidden if used to treat acne) - 2 Weeks
- Retinoids (including fixed drug combinations) - 4 Weeks
- Cosmetic/aesthetic procedures on the face (e.g., comedone extraction, desquamating, or abrasive agents, adhesive cleansing strips) - 1 Week
- Wax epilation - 2 Weeks
- Photodynamic therapy - 6 Weeks
- Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne - 3 months
9. Subject with a wash-out period for systemic treatment less than:
- Corticosteroids, (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), tetracyclines, other antibiotics (except penicillin) - 1 month
- Oral retinoids/isotretinoin - 6 months
- Cyproterone acetate / Chlormadinone acetate - 6 months
- Spironolactone/ Drospirenone - 3 months
- Immunomodulators - 3 months
- Oral contraceptives for acne - 1 month
Note: No time frame period is specified for medicated shaving creams, after-shaves, colognes, astringents, or preparations with alcohol, but their application is prohibited during the study.
10. Subject with active or chronic skin allergies,
11. Subject with known or suspected allergy to the investigational product,
12. Subject who has used tanning booths or lamps or had excessive ultraviolet (UV) radiation exposure within 1 month prior to clinical trial entry or foresees intensive UV exposure during the study (mountain sports, sailing, sunbathing, etc.),
13. Subject who is at risk in terms of precautions, warnings, and contraindications,
14. Subject with a beard or other facial hair that might interfere with study assessments,
15. Subject with an acute / chronic disease or a history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk,
16. Subject under guardianship, hospitalized subject in a public or private institution for a reason other than the research, and subject deprived of his/her freedom,
17. Subject who has participated in another investigational drug or device research study within 30 days prior to enrollment OR is in an exclusion period from a previous clinical trial,
18. Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of trifarotene 50 µg/g cream compared to its vehicle cream in the treatment of moderate acne vulgaris with acne-induced postinflammatory hyperpigmentation (PIH) in subjects with Fitzpatrick Skin Types (FST) I-VI;Secondary Objective: Not applicable;Primary end point(s): Absolute change from Baseline in PIH Overall Disease Severity scores at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method