Acne VulgarisPhase 1NCT01929278
W0265-103: A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers
A Phase 1 study testing CT Gel (clindamycin 1% and tretinoin 0.025%) and Blank patch in people with Acne Vulgaris, run by Stiefel, a GSK Company.
Trial summary
Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified vehicle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- CT Gel (clindamycin 1% and tretinoin 0.025%) and Blank patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 8 Dec 2008to 19 Dec 2008
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The capability of understanding and providing signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
- Male or female subjects aged from 18 to 65 years, inclusive, at time of consent.
- The ability to complete the study and to comply with study instructions.
- Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
- Sexually active females of childbearing potential who agreed to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was defined as one who was biologically capable of becoming pregnant, including perimenopausal women who were less than 2 years from their last menses. Acceptable contraceptive methods included the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of non-hormonal contraception was to have been added until the third continuous month of hormonal contraception was completed.
- Two forms of non hormonal contraception, including intrauterine devices or properly used barrier methods (eg, male or female condoms, diaphragm, or cervical cap). Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, were to have used a form of non-hormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
- Women who were not currently sexually active or lactating agreed to use a medically accepted method of contraception if she became sexually active while participating in the study.
Who cannot join
- Currently diagnosed with cancer or had a previous history of cancer, including skin cancer, or severe photodamaged skin. Severe photodamaged skin was characterized by yellow-gray color, wrinkles with no visible normal skin, and prior skin malignancies.
- Female subjects who were pregnant, attempting to become pregnant, or breast feeding.
- Received any investigational drug within 4 weeks of study day 1 or who were scheduled to receive an investigational drug other than the study product during the study.
- Used contraindicated prescription drugs within 4 weeks or 5 half-lives, whichever was longer, of first dose of study product, unless agreed as not clinically relevant by the principal investigator and the project physician.
- Participated in a previous study of the same study product.
- Current use of any medication which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
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- Suffered from any disease or condition which, in the opinion of the investigator, may have affected the evaluation of the study product or placed the subject at undue risk.
- Any major illness within 30 days before the screening examination.
- Considered immunocompromised or using immunosuppressant drugs.
- Clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- History of known or suspected intolerance to any of the ingredients of the study products (ie, test and comparator products), to the hypoallergenic tape, or to the cotton patches.
- Clinically relevant history or presence of respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Considered unable or unlikely to attend the necessary visits.
- History of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
- Current use or expected use of photosensitizing medications (over-the-counter and prescription), herbal supplements, or any use of a known photosensitizing material.
- Clinically significant skin diseases contraindicating participation or interfering with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
- Investigator inability to evaluate the skin in and around the potential test sites due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin abnormalities.
- Used topical medications (eg, corticosteroids or immunosuppressives) on potential test sites within the last 7 days prior to screening visit 1.
- Currently receiving allergy injections, or due to receive an injection, within 7 days prior to screening visit 1, or expected to begin injections during study participation.
- Used antihistamines or prescription anti inflammatory drugs within 72 hours of the day 1 visit. Permitted exceptions were acetaminophen at recommended doses and aspirin at doses of ≤81 mg/day.
- Participated in any patch test study for irritation or sensitization or any test involving ultraviolet exposures within the last 4 weeks.
- Employees of Hill Top Research or Stiefel Laboratories involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
About this study
Official title: A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers
Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified vehicle. This was a single-center, evaluator-blinded, randomized, placebo (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24 hour single applications of 3 sets of 3 study patches. The study expected to enroll approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel).
After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and 0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75 MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches (set C) was then removed, and those sites served as a non irradiated control. Inflammatory responses and other cutaneous effects were scored 1 hour after patch removal and during follow-up visits at 24, 48, and 72 hours after patch removal.
- Conditions
- Acne Vulgaris
- Being tested
- CT Gel (clindamycin 1% and tretinoin 0.025%), Vehicle gel patch, Blank patch
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Gel (clindamycin 1% and tretinoin 0.025%)Drug
Three CT Gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures.
Vehicle gel patchOther
Three vehicle gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 2. Vehicle gel contained the identical ingredients and packaging as CT Gel but without the active ingredients. All vehicle gel used during the study was from batch ZLU C.
Blank patchOther
Three blank patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 3. Occlusive patches consisted of a non-woven cotton pad (Webril [approximately 2 cm x 2 cm]) covered and secured on all sides by an occlusive hypoallergenic tape (approximately 4 cm x 4 cm).
| Study group | Role | What they receive |
|---|---|---|
| CT Gel patch | Experimental | CT Gel is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1% and tretinoin 0.025%) in a modified vehicle. The test article was placed on a separate occlusive patch at volumes of 200 µL per patch. Receives: Drug: CT Gel (clindamycin 1% and tretinoin 0.025%) |
| Vehicle gel patch | Placebo comparator | The test article was placed on a separate occlusive patch at volumes of 200 µL per patch. Receives: Other: Vehicle gel patch |
| Blank patch | Experimental | Blank patches did not contain CT Gel or vehicle gel. Receives: Other: Blank patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory responses (erythema and local skin reactions) or superficial effects (if observed) will be scored according to the erythema, local skin reaction, and superficial effects grading scales.
In cases where the patch area is larger than the irradiated area, only the irradiated areas will be scored unless reactions outside the irradiated area exhibit unusual responses. Scores represent the presence of clinically significant effects on at least 25% of the test site. Questionable, barely perceptible, or minimal reactions involving less than 25% of the test site will not be considered significant.
Measured: 6 - 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study start8 Dec 2008
- Primary completion19 Dec 2008
- Study completion19 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929278
- Sponsor's protocol ID
- 114729
- Status last verified
- Jul 2017
- First submitted
- 22 Aug 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01929278
- Acronym / sponsor ID
- 114729
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 8 Dec 2008 (actual)
- Primary completion
- 19 Dec 2008 (actual)
- Study completion
- 19 Dec 2008 (actual)
- First posted
- 27 Aug 2013 (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.
Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified vehicle. This was a single-center, evaluator-blinded, randomized, placebo (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24 hour single applications of 3 sets of 3 study patches. The study expected to enroll approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel).
After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and 0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75 MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches (set C) was then removed, and those sites served as a non irradiated control. Inflammatory responses and other cutaneous effects were scored 1 hour after patch removal and during follow-up visits at 24, 48, and 72 hours after patch removal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT Gel patch | Experimental | Drug: CT Gel (clindamycin 1% and tretinoin 0.025%)CT Gel is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1% and tretinoin 0.025%) in a modified vehicle. The test article was placed on a separate occlusive patch at volumes of 200 µL per patch. |
| Vehicle gel patch | Placebo comparator | Other: Vehicle gel patchThe test article was placed on a separate occlusive patch at volumes of 200 µL per patch. |
| Blank patch | Experimental | Other: Blank patchBlank patches did not contain CT Gel or vehicle gel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The capability of understanding and providing signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
- Male or female subjects aged from 18 to 65 years, inclusive, at time of consent.
- The ability to complete the study and to comply with study instructions.
- Possessed Fitzpatrick skin type I (always burns easily; never tans), II (always burns easily; tans minimally), or III (burns moderately; tans gradually) that would not interfere with the reading of any skin responses. Determination of skin types was based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
- Sexually active females of childbearing potential who agreed to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was defined as one who was biologically capable of becoming pregnant, including perimenopausal women who were less than 2 years from their last menses. Acceptable contraceptive methods included the following:
Key exclusion criteria (22 listed)
- Currently diagnosed with cancer or had a previous history of cancer, including skin cancer, or severe photodamaged skin. Severe photodamaged skin was characterized by yellow-gray color, wrinkles with no visible normal skin, and prior skin malignancies.
- Female subjects who were pregnant, attempting to become pregnant, or breast feeding.
- Received any investigational drug within 4 weeks of study day 1 or who were scheduled to receive an investigational drug other than the study product during the study.
- Used contraindicated prescription drugs within 4 weeks or 5 half-lives, whichever was longer, of first dose of study product, unless agreed as not clinically relevant by the principal investigator and the project physician.
- Participated in a previous study of the same study product.
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 |
|---|---|---|
| CT Gel (clindamycin 1% and tretinoin 0.025%)Three CT Gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. | Drug | CT Gel patch |
| Vehicle gel patchThree vehicle gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 2. Vehicle gel contained the identical ingredients and packaging as CT Gel but without the active ingredients. All vehicle gel used during the study was from batch ZLU C. | Other | Vehicle gel patch |
| Blank patchThree blank patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 3. Occlusive patches consisted of a non-woven cotton pad (Webril [approximately 2 cm x 2 cm]) covered and secured on all sides by an occlusive hypoallergenic tape (approximately 4 cm x 4 cm). | Other | Blank patch |
Primary outcome
Inflammatory responses (erythema and local skin reactions) or superficial effects (if observed) will be scored according to the erythema, local skin reaction, and superficial effects grading scales.
Time frame: 6 - 11 days
In cases where the patch area is larger than the irradiated area, only the irradiated areas will be scored unless reactions outside the irradiated area exhibit unusual responses. Scores represent the presence of clinically significant effects on at least 25% of the test site. Questionable, barely perceptible, or minimal reactions involving less than 25% of the test site will not be considered significant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Results for study 114729 can be found on the GSK Clinical Study Register.Link 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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT Gel (clindamycin 1% and tretinoin 0.025%) and Blank patch in people with Acne Vulgaris, run by Stiefel, a GSK Company.
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 8 inclusion and 22 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 18 Jul 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammatory responses (erythema and local skin reactions) or superficial effects (if observed) will be scored according to the erythema, local skin reaction, and superficial effects grading scales. (time frame: 6 - 11 days). 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 18 Jul 2017.