AcnePhase 3NCT02173054
An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne
A Phase 3 study testing Adapalene gel with Eucerin and Adapalene gel in people with Acne, run by Mahidol University at 1 site in Thailand.
Trial summary
Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Adapalene gel with Eucerin and Adapalene gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2014to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or above
- Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
- being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA
Who cannot join
- Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
- Have other active skin diseases at face during 2 weeks before participate the research
- Allergic to adapalene gel and moisturizer
- Have severe or uncontrolled underlying diseases
- Getting pregnant or during breast feeding
- Other types of acne(not acne vulgaris)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluator-blind, Randomized, Vehicle-controlled Efficiency of Adjunctive Usage of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel for Improvement of Local Tolerance in Thai Acne Subjects
Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.
Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).
Read the detailed description
The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.
- Conditions
- Acne
- Being tested
- Adapalene gel with Eucerin, Adapalene gel, Adapalene gel with placebo moisturizer
- Keywords
- Acne, Moisturizer, Efficacy, Irritation
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene gel with EucerinOther
Also called licochalcone A + L-carnitine + decanediol (Eucerin), Adapalene gel (Differin)
Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
Adapalene gelOther
Also called Adapalene gel (Differin)
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
Adapalene gel with placebo moisturizerOther
Also called •Adapalene gel (Differin)
Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Adapalene gel | Placebo comparator | Evening
* Wash face by prepared facial foam and dry your face
* Apply adapalene gel all over the face Receives: Other: Adapalene gel |
| Adapalene gel with placebo moisturizer | Placebo comparator | Morning
* Wash face by prepared facial foam and dry their face
* Apply placebo cream all over the face
Evening
* Wash face by prepared facial foam and dry your face
* Apply adapalene gel all over the face
* Apply placebo cream all over the face Receives: Other: Adapalene gel with placebo moisturizer |
| Adapalene gel with Eucerin | Active comparator | Morning
* Wash face by prepared facial foam and dry their face
* Apply Eucerin cream all over the face
Evening
* Wash face by prepared facial foam and dry your face
* Apply adapalene gel all over the face
* Apply Eucerin cream all over the face Receives: Other: Adapalene gel with Eucerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Undesirable Effects
- Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
- The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.
Measured: 2nd week, 4th week, and 8th week
Skin Tolerability: Skin Sebum Content and Skin Hydration
Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Measured: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin Tolerability: Transepidermal Water Loss (TEWL)
Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
Measured: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Secondary outcomes (2)
Reduction of Severity of Acne
- Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
- Total acne lesions = inflammatory + noninflammatory acne lesions
- Reduction of lesions counts are considered to be a better outcome
Measured: baseline, 2nd week, 4th week and 8th week
Reduction of Severity of Acne: Acne Severity Index (ASI)
- The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
- Decrease of ASI score are considered to be a better outcome
Measured: baseline, 2nd week, 4th week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionJul 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Papapit Tuchinda, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173054
- Sponsor's protocol ID
- Acne and adjuctive moisturizer
- Status last verified
- Nov 2016
- First submitted
- 18 Jun 2014
- Last updated
- 23 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.
PubMed 26293170
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluator-blind, Randomized, Vehicle-controlled Efficiency of Adjunctive Usage of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel for Improvement of Local Tolerance in Thai Acne Subjects
- ClinicalTrials.gov ID
- NCT02173054
- Acronym / sponsor ID
- Acne and adjuctive moisturizer
- Conditions
- Acne
- Keywords
- Acne, Moisturizer, Efficacy, Irritation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 26 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.
Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).
Detailed description
The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adapalene gel | Placebo comparator | Other: Adapalene gelEvening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face |
| Adapalene gel with placebo moisturizer | Placebo comparator | Other: Adapalene gel with placebo moisturizerMorning * Wash face by prepared facial foam and dry their face * Apply placebo cream all over the face Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face * Apply placebo cream all over the face |
| Adapalene gel with Eucerin | Active comparator | Other: Adapalene gel with EucerinMorning * Wash face by prepared facial foam and dry their face * Apply Eucerin cream all over the face Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face * Apply Eucerin cream all over the face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years old or above
- Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
- being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA
Key exclusion criteria (6 listed)
- Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
- Have other active skin diseases at face during 2 weeks before participate the research
- Allergic to adapalene gel and moisturizer
- Have severe or uncontrolled underlying diseases
- Getting pregnant or during breast feeding
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 |
|---|---|---|
| Adapalene gel with EucerinAlso: licochalcone A + L-carnitine + decanediol (Eucerin), Adapalene gel (Differin)Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed | Other | Adapalene gel with Eucerin |
| Adapalene gelAlso: Adapalene gel (Differin)Adapalene gel: 2 fingertip unit to cover all over the face before going to bed | Other | Adapalene gel |
| Adapalene gel with placebo moisturizerAlso: •Adapalene gel (Differin)Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed | Other | Adapalene gel with placebo moisturizer |
Primary outcome
Reduction of Undesirable Effects
Time frame: 2nd week, 4th week, and 8th week
* Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week. * The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.
Skin Tolerability: Skin Sebum Content and Skin Hydration
Time frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Skin Tolerability: Transepidermal Water Loss (TEWL)
Time frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
2 secondary outcomes
Reduction of Severity of Acne
Time frame: baseline, 2nd week, 4th week and 8th week
Reduction of Severity of Acne: Acne Severity Index (ASI)
Time frame: baseline, 2nd week, 4th week and 8th week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26293170Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.
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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.
Papapit Tuchinda, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adapalene gel with Eucerin and Adapalene gel in people with Acne, run by Mahidol University at 1 site in Thailand.
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 3 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: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 26 Feb 2016). 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?
Reduction of Undesirable Effects (time frame: 2nd week, 4th week, and 8th week). The study lists 3 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 NCT02173054, which also lists 1 linked publication.
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 23 Jan 2017.