CTRI/2018/08/015167 [Registered on: 02/08/2018] Trial Registered Prospectively
Last Modified On:
10/01/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
To Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel in patients with Acne Vulgaris.
Scientific Title of Study
A Randomised, Double-blind, Multicentre, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC Once Daily 10 mg/g and 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRL111735 version 1.1 date 7 Feb 18,addendum 8 Jun 18
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Associate Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Room no. 01, 2nd floor, department clinical trials, Cliantha Research Limited
Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev
Ahmadabad GUJARAT 380054 India
Phone
9879590828
Fax
7966219549
Email
ddomadia@cliantha.in
Details of Contact Person Scientific Query
Name
DrAnkesh Barnwal
Designation
Manager Medical Services
Affiliation
Cliantha Research Limited
Address
Room no. 04, 3rd floor, department medical services, Cliantha Research Limited
Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev
Ahmadabad GUJARAT 380054 India
Phone
9909019497
Fax
7966219545
Email
abarnwal@cliantha.in
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Project Manager – Clinical Trials
Affiliation
Cliantha Research Limited
Address
Room no. 04, 2nd floor, department clinical trials, Cliantha Research Limited
Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev.
Ahmadabad GUJARAT 380054 India
Phone
9712908404
Fax
7966219549
Email
dverma@cliantha.in
Source of Monetary or Material Support
Morningside Healthcare Ltd.
Morningside House
Unit C, Harcourt Way
Meridian Business Park
Leicester
LE19 1WP
UK
Primary Sponsor
Name
Morningside Healthcare Ltd
Address
Morningside House
Unit C, Harcourt Way
Meridian Business Park
Leicester
LE19 1WP
UK
Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel
Subject have to apply a thin film of gel over entire area of affected skin of face, using fingertips once daily, in the evening for 77 consecutive days.
Comparator Agent
DUAC 10 mg/g and 50 mg/g Gel
Subject have to apply a thin film of gel over entire area of affected skin of face, using fingertips once daily, in the evening for 77 consecutive days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1. Healthy male or non-pregnant female aged more than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of Acne vulgaris.
2. On the face, more than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones) AND more than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodules.
3. Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
4. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
5. If female of childbearing potential, willing to use an acceptable form of birth control during the study.
6. Willing to provide written informed consent or assent, as applicable.
ExclusionCriteria
Details
1. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
2. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g. chloracne and drug induced acne).
3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
4. History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients.
5. Use within 6 months prior to baseline (Randomisation) of oral retinoids (e.g. Accutane) or therapeutic vitamin A supplements of greater than 10,000 units per day (multivitamins are allowed).
6. Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
7. Use on the face within 1 month prior to baseline (Randomisation) of 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel.
8. Use within 1 month prior to baseline (Randomisation) of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
9. Use within 2 weeks prior to baseline (Randomisation) of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics.
10. Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation).
11. Used astringents and toners for less than 2 weeks prior to the start of the study. The subject must have had an established regimen for at least 2 weeks prior to enrolment and must not have anticipated changing their regimen during the conduct of the entire study.
12. Used abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers, moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids within the previous 2 weeks.
13. Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [more than 2000 IU per day], vitamin B6 [more than 2 mg] or vitamin B12 [more than 1 mg per day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
14. Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
15. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
16. Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
17. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
18. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
19. Current drug or alcohol abuse.
20. Lived in the same household as currently enrolled subjects.
21. Female subjects who are breast-feeding or planning to become pregnant.
22. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
23. Clinically significant abnormal findings or condition (other than acne), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Primary Efficacy Endpoint-
. Mean percent change from baseline to week 11 for inflammatory (papules and pustules) lesions count
Secondary Efficacy Endpoints:
.Mean percent change from baseline to week 11 in the non-inflammatory lesion count.
.Percentage of subjects with clear or almost clear at week 11 by IGA score [Grade 0 or 1] as compared to baseline
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A Randomised, Double-blind, Multicentre, Parallel-group, Active & Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC® Once Daily 10 mg/g and 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris.
530 subjects will be required to be enrolled (randomised) in the study for around 91 days that includes screening period of 14 days and treatment period of 11 weeks.
The end of the study will be the date of the last study visit for the last subject in the study.
The study will commence only after the approval from the Local Regulatory Approval (DCGI).
The maximum estimated period for each subject on study is anticipated to be approximately 11 weeks.