To Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g and Benzoyl Peroxide 50 mg/g Gel in patients with Acne Vulgaris.

Completed

Conditions: Acne vulgaris,

Registration Number: CTRI/2018/08/015167

Lead Sponsor: Morningside Healthcare Ltd

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 DUACÂ® 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 530

Inclusion Criteria

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.
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.
Investigatorâ€™s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
If female of childbearing potential, willing to use an acceptable form of birth control during the study.
Willing to provide written informed consent or assent, as applicable.

Exclusion Criteria

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).
Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g. chloracne and drug induced acne).
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
Well-trimmed moustaches are allowed.
History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients.
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).
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.
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.
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.
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.
Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation).
Used astringents and toners for less than 2 weeks prior to the start of the study.
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 Î±- or Î²-hydroxy acids within the previous 2 weeks.
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.
Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
Current drug or alcohol abuse.
Lived in the same household as currently enrolled subjects.
Female subjects who are breast-feeding or planning to become pregnant.
Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint-	At baseline, week 2, week 5, week 8 and week 11.
. Mean percent change from baseline to week 11 for inflammatory (papules and pustules) lesions count	At baseline, week 2, week 5, week 8 and week 11.
Secondary Efficacy Endpoints:	At baseline, week 2, week 5, week 8 and week 11.
.Mean percent change from baseline to week 11 in the non-inflammatory lesion count.	At baseline, week 2, week 5, week 8 and week 11.
.Percentage of subjects with clear or almost clear at week 11 by IGA score [Grade 0 or 1] as compared to baseline	At baseline, week 2, week 5, week 8 and week 11.

Secondary Outcome Measures

Name	Time	Method
Safety Endpoints:	.Treatment Emergent Adverse events (TEAEs)

Trial Locations

Locations (21): Apple Hospital
🇮🇳
Surat, GUJARAT, India
B. J. Medical College and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
B.J. Govt. Medical College
🇮🇳
Pune, MAHARASHTRA, India
DHL Research centre
🇮🇳
Ahmadabad, GUJARAT, India
Dr. D. Y. Patil Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Dr. Jivraj Mehta Smarak Health Foundation
🇮🇳
Ahmadabad, GUJARAT, India
Dr. Vasantrao Medical College, Hospital & Research centre
🇮🇳
Nashik, MAHARASHTRA, India
Father Muller Medical College & Hospital
🇮🇳
Kannada, KARNATAKA, India
Government Medical College & SSG Hospital
🇮🇳
Vadodara, GUJARAT, India
Government Medical College and hospital
🇮🇳
Nagpur, MAHARASHTRA, India
Scroll for more (11 remaining)
Apple Hospital
🇮🇳Surat, GUJARAT, India
Dr Jagdish Sakhia
Principal investigator
8155900010
jagdish.sakhia@gmail.com