Acne VulgarisPhase 3NCT02005666
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
A Phase 3 study testing Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel and DUAC® Gel in people with Acne Vulgaris, run by Zydus Lifesciences Limited at 36 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel and DUAC® Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Nov 2013to 28 Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
- 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).
- Investigator'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.
- 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.
- Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)
Who cannot join
- 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).
- Patients who have acne conglobata, acne fulminans 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 benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- Patients who have a severe or intense irritation on the Face.
- 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).
Show all 23Show fewer
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
- Concomitant use of tanning booths or sunbathing.
- A significant medical history of or are currently immunocompromised
- Have any systemic or dermatologic disease that may affect the evaluation of study results.
- Have a history of regional enteritis, ulcerative colitis, pseudomembranous 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.
- Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization.
- 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 enrollment.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
India24 sites
NHL Medical College and VS Hospital
Ahmedabad, Gujarat, 380006
AMC-MET Medical College, Sheth LG General Hospital,
Ahmedabad, Gujarat, 380008
Sanjeevani Hospital,
Ahmedabad, Gujarat, 380015
Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,
Ahmedabad, Gujarat, 380016
Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -
Bangalore, Karnataka, 560 052
Dept of Dermatology, Kempegowda Institute of Medical Sciences
Bangalore, Karnataka, 560004
Sapthagiri Hospital,
Bangalore, Karnataka, 560073
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Punjab, 160012
Ganga Ram Hospital,
Delhi, 110 060
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012
Gandhi Hospital,
Hyderabad, Andhra Pradesh, 500048
Institute of Post graduate medical and Research
Kolkata, West Bengal, 700020
M.V. Hospital and research Center
Lucknow, Uttar Pradesh, 226003
Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,
Mumbai, Gujarat, 400 008
Dept of Skin & STD, JSS Hospital Ramanuja Road, -
Mysore, Karnataka, 570004
Government Medical Collge
Nagpur, Maharashtra, 440003
NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,
Nagpur, Maharashtra, 440019
Dr. D Y Patil Hospital and Research Center
Navi Mumbai, Maharashtra, 400706
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, 110002
Jehangir Clinical Development Center
Pune, Maharashtra, 411001
Medipoint Hosp
Pune, Maharashtra, 411007.
Department of Dermatology, New Civil Hospital and Government Medical College
Surat, Gujarat, 395001
Baroda Medical College
Vadodara, Gujarat, 390001
King George Hospital
Visakhapatnam, Andrapradesh, 530002
United States12 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Visions Clinical Research
Boynton Beach, Florida, 33472
Discover Research
Bryan, Texas, 77802
Dermatology Research Instititue
Coral Gables, Florida, 33146
Universal BioPharma Research
Dinuba, California, 93618
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Specialists
Louisville, Kentucky, 40202
International Dermatology Research, Inc.
Miami, Florida, 33144
Skin Specialists, PC
Omaha, Nebraska, 68144
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Research Across America
Santa Ana, California, 92705
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
About this study
Official title: 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
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.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel, DUAC® Gel, Placebo
- Keywords
- Acne Vulgaris, DUAC, CADILA, CLIANTHA
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% GelDrug
Also called 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL
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
DUAC® GelDrug
Also called DUAC® Gel (of Stiefel Laboratories
Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
PlaceboDrug
Also called Placebo (Vehicle Gel)
Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Test-Cadila healthcare limited | Experimental | 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 Receives: Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel |
| Reference | Active comparator | 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 Receives: Drug: DUAC® Gel |
| Placebo | Placebo comparator | Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count.
Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Measured: week 11
Secondary outcomes (2)
Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count.
Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Measured: week 11
Proportion of Subjects With a Clinical Response of "Success" at Week 11
Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment.
Percentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population.
IGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions
Measured: Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Dharmesh Domadia, M.D, Study director, Cliantha Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005666
- Sponsor's protocol ID
- CRL/CT/09/11-12
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2013
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12. doi: 10.1002/bdd.2510100508.
PubMed 2804254Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.
PubMed 19911678
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02005666
- Acronym / sponsor ID
- CRL/CT/09/11-12
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, DUAC, CADILA, CLIANTHA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test-Cadila healthcare limited | Experimental | Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% GelDrug:-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 |
| Reference | Active comparator | Drug: DUAC® GelDrug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboDrug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
- 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).
- Investigator'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.
Key exclusion criteria (23 listed)
- 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).
- Patients who have acne conglobata, acne fulminans 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 benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- Patients who have a severe or intense irritation on the Face.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% GelAlso: 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHLDrug:-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 | Drug | Test-Cadila healthcare limited |
| DUAC® GelAlso: DUAC® Gel (of Stiefel LaboratoriesDrug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days | Drug | Reference |
| PlaceboAlso: Placebo (Vehicle Gel)Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days | Drug | Placebo |
Primary outcome
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
Time frame: week 11
Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2804254Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12. doi: 10.1002/bdd.2510100508.
- Background: PubMed 19911678Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.
- 1\. Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam PhysicianLink provided by the sponsor.
- 2\. NilFroushzadeh MA, Siadat AH, Baradaran EH, Moradi S. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus Tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild toLink provided by the sponsor.
- Cleocin T® Prescribing InformationLink provided by the sponsor.
- Guin JD, Lummis WL. Comedonal levels of free clindamycin following topical treatment with a 1% solution of clindamycin phosphate. Journal of the American Academy of DermatologyLink provided by the sponsor.
- Plaisnce KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents ChemotherLink provided by the sponsor.
- DUAC® Gel Prescribing InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Dharmesh Domadia, M.D study director
Cliantha Research Limited
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel and DUAC® Gel in people with Acne Vulgaris, run by Zydus Lifesciences Limited at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions. (time frame: week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.