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To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel

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ClinicalTrials.gov Identifier: NCT02005666
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Tracking Information
First Submitted Date  ICMJE November 28, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date February 1, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions. [ Time Frame: week 11 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02005666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Mean percent change from baseline to week 11 in the non-inflammatory lesion count [ Time Frame: week 11 ]
  • Proportion of subjects with a clinical response of "success" at week 11 [ Time Frame: Week 11 ]
    Success will be defined as an IGA score that is at least 2 grades less than the baseline assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • Mean percent change from baseline to week 11 in the non-inflammatory lesion count [ Time Frame: week 11 ]
  • Proportion of subjects with a clinical response of "success" at week 11 [ Time Frame: Week 11 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Official Title  ICMJE A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC® Gel (of Stiefel Laboratories, USA) Versus Placebo (Vehicle Gel) in the Ratio of 2:2:1 Respectively, in Patients With Acne Vulgaris
Brief Summary

This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study.

The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo respectively.

Total study duration will be for a period of 78 days which includes treatment duration of 77 days.

850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel
    Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Other Name: 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL
  • Drug: DUAC® Gel
    Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Other Name: DUAC® Gel (of Stiefel Laboratories
  • Drug: Placebo
    Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Other Name: Placebo (Vehicle Gel)
Study Arms  ICMJE
  • Experimental: Test-Cadila healthcare limited
    Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Intervention: Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel
  • Active Comparator: Reference
    Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Intervention: Drug: DUAC® Gel
  • Placebo Comparator: Placebo
    Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2013)
850
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 28, 2016
Actual Primary Completion Date September 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
  2. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
  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. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
  7. Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)

Exclusion Criteria:

  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. Patients who have acne conglobata, acne fulminans 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 benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
  5. Patients who have a severe or intense irritation on the Face.
  6. Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
  7. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
  8. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
  9. Use within 1 month prior to baseline (Randomization) 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.
  10. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
  11. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization).
  12. Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
  13. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
  14. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
  15. Concomitant use of tanning booths or sunbathing.
  16. A significant medical history of or are currently immunocompromised
  17. Have any systemic or dermatologic disease that may affect the evaluation of study results.
  18. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
  19. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
  20. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
  21. Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization.
  22. Female subjects who are breast-feeding or planning to become pregnant.
  23. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005666
Other Study ID Numbers  ICMJE CRL/CT/09/11-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cadila Healthcare Limited
Study Sponsor  ICMJE Cadila Healthcare Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr Charu Gautam, M.D,DNB Cliantha Research Limited
PRS Account Cadila Healthcare Limited
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP