CTRI/2024/08/072412
Not yet recruiting
Phase 4
A prospective, multi center, open label phase IV clinical study to evaluate the safety and efficacy of Trifarotene or Aklief 50 microgram per gram cream in subjects with acne vulgaris over 12 weeks. - NI
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GALDERMA SA
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects of either sex aged 12 years and above who have given written informed consent or assent to participate in the study. Subjects 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 procedure, samples and photos are collected.(Note This DCGI approved trial has no upper age limit subjects aged more than or equal to 12 years are
- •inclusive).
- •2\. Subjects with facial acne vulgaris severity grade of 2\-3 (mild to moderate) on Investigator Global Assessment (IGA) Scale and truncal acne vulgaris of severity grade of 2\-3 (mild to moderate) on the Physician Global Assessment (PGA) Scale at screening and Baseline visits.
- •3\. Subject has a minimum of 20 inflammatory and 20 non\-inflammatory lesions on the face and trunk.
- •4\. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline Visit.
- •5\. Female subjects of childbearing potential 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: Progestogen\-only oral hormonal contraception, Combination of male condom with cap, diaphragm, or sponge with spermicide, Combined (estrogen\- and progestogen\-containing) oral, intravaginal, or transdermal hormonal contraception, Injectable or implanted hormonal contraception, Intrauterine devices or intrauterine hormone\-releasing system and Bilateral tubal ligation at least 3 months before the study, Bilateral vasectomy of partner at least 3 months before the study.
- •6\. Female of non\-childbearing potential, hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
Exclusion Criteria
- •1\. Subjects with severe forms of acne, and has more than 1 nodule on either the face or trunk and acne cyst on face or trunk at screening and Baseline Visit.
- •2\. Subjects with beard or facial hair, tattoos on the application area which interfers with study assessment.
- •3\. Subjects with any uncontrolled or serious disease or any medical or surgical condition, has known or suspected allergies or sensitivities to any components of any of the study drugs.
- •4\. Females who are Pregnant, lactating women or planning pregnancy.
- •5\. Female subject of childbearing potential using combined oral contraceptives approved as acne treatments in whom the dose has not been stable for at least 6 months prior to the Baseline visit.
- •6\. Subject with known impaired hepatic or renal functions and with an acute / chronic disease or a history of major medical or psychiatric condition or surgical interventions.
- •7\. Subjects with a washout period for topical treatment or procedures on the face and trunk i.e, less than 2 weeks for 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), less than 4 weeks for Topical Retinoids (including fixed drug combinations), less than 1 week for Cosmetic/aesthetic procedures on the face (e.g., comedone extraction, desquamating, or abrasive agents, adhesive cleansing strips), less than 2 weeks for Wax epliation, less than 6 weeks for Photodynamic therapy and less than 3 months for Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne.
- •8\. Subject with a washout period for systemic treatment i.e., less than 1 month for Corticosteroids, (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), tetracyclines, other antibiotics (except penicillin), less than 6 months for Oral retinoids/isotretinoin, less than 6 months for Cyproterone acetate / Chlormadinone acetate, less than 3 months for Spironolactone/ Drospirenone, less than 3 months for Immunomodulators and less than 1 month for Oral contraceptives for acne.
- •9\. 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.)
- •10\. Subject who is at risk in terms of precautions, warnings, and contraindications.
Outcomes
Primary Outcomes
Not specified
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