AcnePhase 4NCT01111994
Efficacy & Safety of Clindamycin and Tretinoin in Acne
A Phase 4 study testing Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in people with Acne, run by Callender Center for Clinical Research at 2 sites in United States.
Trial summary
The purpose of this study is ascertain the efficacy and safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post Inflammatory Hyperpigmentation in patients with skin of color. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
- Photo skin types IV - VI
- Ages 12 and older
- Both sexes
- Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
- Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives
Who cannot join
- Seborrheic dermatitis
- PIH of solely dermal origin
- Acne vulfaris known to be resistant to oral antibiotics
- Use of erythromycin-containing products
- Use of neuromuscular blocking agents
- Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Callender Center for Clinical Research
Mitchellville, Maryland, 20721
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107
About this study
Official title: Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
The purpose of this study is ascertain the efficacy and safety of Clindamycin
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
Read the detailed description
Acne is a chronic disorder of the pilosebaceous glands characterized by
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
- Conditions
- Acne
- Being tested
- Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
- Keywords
- hyperpigmentation
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% GelDrug
Also called Ziana Gel
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of acne and post inflammatory hyperpigmentation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Callender Center for Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Society Hill Dermatology
- Investigators
- Valerie Callender, MD, Principal investigator, Callender Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111994
- Sponsor's protocol ID
- VDC2009Z
- Status last verified
- May 2010
- First submitted
- 26 Apr 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
- ClinicalTrials.gov ID
- NCT01111994
- Acronym / sponsor ID
- VDC2009Z
- Conditions
- Acne
- Keywords
- hyperpigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Callender Center for Clinical ResearchUniversity, hospital or other
- Collaborators
- Society Hill Dermatology
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is ascertain the efficacy and safety of Clindamycin
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
Detailed description
Acne is a chronic disorder of the pilosebaceous glands characterized by
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
- Photo skin types IV - VI
- Ages 12 and older
- Both sexes
- Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
Key exclusion criteria (6 listed)
- Seborrheic dermatitis
- PIH of solely dermal origin
- Acne vulfaris known to be resistant to oral antibiotics
- Use of erythromycin-containing products
- Use of neuromuscular blocking agents
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% and Tretinoin 0.025% GelAlso: Ziana GelClindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months | Drug | – |
Primary outcome
Improvement of acne and post inflammatory hyperpigmentation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
- Home page to the Callender Skin \& Laser Center that includes "Research Studies" sectionLink 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.
Valerie Callender, MD principal investigator
Callender Center for Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in people with Acne, run by Callender Center for Clinical Research at 2 sites in United States.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Improvement of acne and post inflammatory hyperpigmentation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2010.