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AcnePhase 3NCT01796665

A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris

A Phase 3 study testing Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% and Acanya Gel in people with Acne, run by Padagis LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to evaluate the efficacy and safety of Perrigo's test formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to the already marketed formulation, Acanya gel in patients with acne vulgaris. Read more about this study

Who is it for?
Ages 12 to 40 years
Conditions the study is for
Acne
What is being tested?
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% and Acanya Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,180 participants
Where
No sites listed yet
Study dates
Feb 2012to Feb 2013
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

  • Subject and/or parent or legally authorized representative must sign an Institutional Review Board (IRB) approved written informed consent/assent.
  • Male or female, 12 to 40 years of age, inclusive.
  • Definite clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count between 20 and 50 and a non-inflammatory (open and closed comedones) lesion count between 25 and 100 and no more than 2 nodulocystic lesions (i.e., nodules and cysts) including those present on the nose.
  • Baseline Investigator's Global Assessment Score of 3 (moderate severity) or 4 (severe) on a severity scale of 0 to 4.
  • Willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other topical acne medication or topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and are able to complete the study.
  • In general good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
  • Females of childbearing potential (excluding women who are surgically sterilized or post menopausal for at least 2 years), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: Oral Contraceptives, Contraceptive patches, Contraceptive Injection (Depo-Provera), Contraceptive Implant (Implanon), Vaginal Contraceptive (Nuva-Ring), IUD, hormonal IUD (Mirena); double-barrier methods (e.g. condom and spermicide) and abstinence with a documented second acceptable method of birth control should subject become sexually active. A sterile sexual partner is not considered an adequate form of birth control. Subjects entering the trial that are on hormonal contraceptives must have been on this method for at least 3 months (90 days) prior to the trial and continue the method for the duration of the trial. Subjects who had used hormonal contraception and stopped must have stopped no less than 3 months (90 days) prior to baseline.

Who cannot join

  • Pregnant, breast feeding, or planning a pregnancy within the study participation period.
  • More than 2 facial nodulocystic lesions (i.e. nodules and cysts).
  • Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
  • Active cystic acne or Polycystic Ovarian Syndrome.
  • History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
  • Use of neuromuscular blocking agents (nondepolarizing agents and depolarizing agents)
Show all 26Show fewer
  • Any other facial skin condition that might interfere with acne vulgaris diagnosis and/or assessment (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
  • Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
  • History of unresponsiveness to topical Clindamycin Phosphate and/or benzoyl peroxide therapy.
  • Use of systemic Clindamycin products 4 weeks prior to baseline or throughout the study.
  • History of hypersensitivity or allergy to Clindamycin Phosphate, benzoyl peroxide and/or any ingredient in the study medication.
  • Use within 6 months prior to baseline or during the study of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
  • Use within 30 days prior to baseline or during the study of therapeutic vitamin D supplement (daily multivitamins with total 800IU Vitamin D are allowed).
  • Use of medications known to exacerbate acne (Vitamin B12, lithium, corticosteroids; Vitamin B12, etc as part of a multivitamin regimen is allowed).
  • Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives and androgens) 3 months prior to base-line or throughout the study. Use of such therapy must remain constant during the study.
  • Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion).
  • Use within 30 days prior to baseline or during the study of 1) systemic steroids*, 2) systemic (e.g., oral or injectable) antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory or immunosuppressive agents. (*Intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose.)Subjects may use Acetaminophen for pain relief, as needed throughout the study).
  • Use within 14 days prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical anti-acne medications (e.g. Benzoyl peroxide, retinoids, azelaic acid, α-hydroxy/glycolic acid, Clindamycin, etc.) including OTC preparations 4) benzoyl peroxide, 5) topical anti-inflammatory agents, or 6) topical antibiotics.
  • Use on the face within 30 days prior to baseline 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 of medicated cleansers (e.g. benzoyl peroxide, salicylic acid, sulfur or triclosan) within 2 weeks of study start and throughout the study.
  • Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
  • Use of Spironolactone for 4 weeks prior to baseline visit and throughout the study period is prohibited.
  • Use of Antipruritics, including antihistamines within 24 hours of all study visits (Visit 1 through Visit 4).
  • Participation in any clinical study involving an investigational product or device in the 4 weeks prior to study entry or throughout the study.
  • Previous enrollment in this current study.
  • Use of tanning booths, sun lamps, sunbathing or excessive exposure to the sun 1 week prior to enrollment and throughout the study.

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd. Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel (Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5%), and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

The objective of this study was to evaluate the efficacy and safety of Perrigo's test formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to the already marketed formulation, Acanya gel in patients with acne vulgaris.

Conditions
Acne
Being tested
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%, Acanya Gel, Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
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 and Benzoyl Peroxide Topical Gel 1.2%/2.5%Drug

    Also called Test product

  • Acanya GelDrug

    Also called Reference product

  • Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% productDrug

    Also called Placebo product

Study groups in NCT01796665
Study groupRoleWhat they receive
Test productExperimentalClindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Receives: Drug: Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
Reference productActive comparatorAcanya Gel applied to the affected areas of the face once daily.
Receives: Drug: Acanya Gel
Placebo productPlacebo comparatorPlacebo of the Test product applied to the affected areas of the face once daily.
Receives: Drug: Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count

    Per protocol population

    Measured: Baseline to week 12

  2. Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count

    Measured: Baseline to week 12

Secondary outcomes (1)

  1. Clinical Success on Investigator's Global Evaluation

    Percentage of subjects with a clinical response of "success", defined as an IGA score that is at least 2 grades less than the baseline assessment.

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2013 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796665
Sponsor's protocol ID
PRG-NY-12-005
Status last verified
Oct 2021
First submitted
18 Feb 2013
Last updated
22 Oct 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% and Acanya Gel in people with Acne, run by Padagis LLC.

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 26 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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 20 Jan 2021). 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 in the Inflammatory (Papules and Pustules) Lesion Count (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. 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 NCT01796665.

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 22 Oct 2021.

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