CTRI/2021/06/034069 [Registered on: 08/06/2021] Trial Registered Prospectively
Last Modified On:
29/07/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Adapalene 0.3% - Benzoyl peroxide 2.5% gel in subjects with Moderate to Severe Acne Vulgaris
Scientific Title of Study
A prospective, multicenter, open label, phase IV study to evaluate safety and efficacy of Adapalene 0.3% - Benzoyl peroxide 2.5% gel in subjects with Moderate to Severe Acne Vulgaris.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT-CE-AC-2020:Version 1.0 dated 18-Sep-2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Devesh Kumar
Designation
Director Clinical Trial Operations
Affiliation
CliniExperts Research Services Private Limited
Address
Unit No. 325, City Center Mall, Plot no. 5,
Sector 12, Dwarka
Institutional Ethics Committee Om Sai Onco Surgery Multispecialty Centre R.S. No. 457/10 C, Dr. Lad Colony Sugar Mil Corner, Main Road Kasaba Bawada, Kolhapur-416006
Approved
Institutional Ethics Committee, BMCH Basaveshwara Medical College and Hospital, NH-4 Bypass, KHB Colony Chitradurga - 577502
Approved
Institutional Ethics Committee, College of Medicine & JNM Hospital, Block A, Kalyani, Nadia, West Bengal - 741235
Approved
Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh – 221005
Mode and frequency of administration - Topical, once daily in the evening after washing.
Total Daily Dose: 4 pea-sized amounts (to cover
whole face, e.g. one on the forehead, one on the chin and one on each cheek.
Duration of treatment: 12 Weeks.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1 Male or female subject of at least 12 years old up to 40 years of age inclusive.
2.Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
b. A minimum of 25-100 inflammatory lesions (papules and pustules); and
c. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
d.No more than two acne nodules (≥ 1 cm)
3.Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit (Visit 1)
4.Female subjects of childbearing potential must practice an effective method of contraception during the clinical trial and at least 1 month after the last clinical trial treatment application: medical contraception [combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with stable dose for 1 month prior to clinical trial entry, bilateral tubal ligation, hormonal Intra-Uterine Device (IUD) inserted at least 1 month prior to clinical trial entry, strict abstinence (1 month prior to trial entry and agrees to continue for the duration of the trial), condom with spermicide, vasectomized partner (for at least 3 months prior to clinical trial entry)
5.Females of non-childbearing potential, e.g. Premenses, Post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral oophorectomy.
6.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 procedure
7.Subject willing and able to comply with the requirements of the trial protocol, in particular, subject must adhere to the visit schedule, concomitant therapy prohibitions, and must be compliant to the treatment
8.Subject must be willing to be photographed. Subject (and parents/guardian if subject is under18 years of age) must be willing to consent for the same
ExclusionCriteria
Details
1.Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodule cystic acne, acne requiring systemic treatment,
2.Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea on the face
3.Prior failure to treatment with Adapalene 0.3% - BPO 2.5% Gel
4.Subject with damaged facial skin (e.g. tattoo, cuts, skin abrasion, eczema or sunburned skin)
5.Female subject who is pregnant, lactating or planning a pregnancy during the trial
6.Subject with known impaired hepatic or renal functions,
7.Subject with a wash-out period for topical treatment or procedures on the face less than:
Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxy acids, Zinc containing treatments, , antiseptics, other anti-inflammatory products or other acne treatments (for example salicylic acid treatments/ transdermal contraceptives are forbidden if used to treat acne)2 weeks Retinoids 4 weeksCosmetic/aesthetic procedures on the face (e.g., comedones 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.
8.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/ anti-androgens / Cyproterone acetate / Chlormadinone acetate 6 months
Spironolactone/ Drospirenone (except if at a stable dose for at least 3 months for drospirenone) 3 months
Immunomodulators 3 months
Oral contraceptives/ oral dapsone for acne 1 month
9.Subject with active or chronic skin allergies,
10.Subject with known or suspected allergy to the investigational product
11.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 trial (mountain sports, sailing, sunbathing, etc.),
12.Subject who is at risk in terms of precautions, warnings, and contraindications Subjects with active infection who needs administration of antibiotics
13.Subject with a beard or other facial hair that might interfere with trial assessments.
14.Subject with an acute / chronic disease, uncontrolled systemic 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.
15.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,
16.Subject who has participated in another investigational product or device research trial within 30 days prior to enrolment
17.Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate Safety and tolerability of Adapalene 0.3% - Benzoyl peroxide 2.5% gel for treatment of Moderate to Severe Acne Vulgaris by assessing below parameters:
Endpoint: Local tolerance: Raw value at each visit and worst-score across visit, % of Subjects across scores at each post-baseline visit
•Adverse Events throughout the trial
Endpoint: Incidence of adverse events throughout the trial
Baseline, Week 2, Week 8 & Week 12
Secondary Outcome
Outcome
TimePoints
•Mean percent change in lesion counts (inflammatory and non-inflammatory) will be assessed
o Inflammatory lesions: papules and pustules
oNon Inflammatory lesions: open and closed comedones
•Global Assessment of Improvement at Week 12
Baseline, Week 2, Week 8 & Week 12
•Global Assessment of Improvement at Week 12
Baseline & Week 12/Early termination
Target Sample Size
Total Sample Size="122" Sample Size from India="122" Final Enrollment numbers achieved (Total)= "122" Final Enrollment numbers achieved (India)="122"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
It is a phase IV clinical study which involves the collection of clinical data to evaluate the safety and effectiveness of Adapalene 0.3% - Benzoyl peroxide 2.5% gel in subjects with Moderate to Severe Acne Vulgaris
Acne vulgaris is a disorder of the pilosebaceous gland occurring usually at puberty but can also be seen in adult age.[1] The disease characterized by the formation of open and closed comedones (non-inflammatory lesions), papules, pustules, and nodulocystic lesions (inflammatory lesions).
Hence this clinical phase IV studies will be done just to verify the safety and effectiveness of Adapalene 0.3% - Benzoyl peroxide 2.5% gelin subjects with Moderate to Severe Acne Vulgaris.