AcneANTI-ACNENCT01948570
Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
An observational study of Acne, run by Derming SRL at 1 site in Italy.
Trial summary
Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jun 2013
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be conducted on volunteers of both genders, aged > 16 years old: 20 subjects presenting acne of mild/moderate grade not in therapy (GROUP 1) and 20 subjects presenting acne of moderately severe/severe grade in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2).
Who may be able to join
- both genders;
- age > 16 years old;
- acne of mild/moderate grade, not in therapy (GROUP 1);
- acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
- accepting to follow the instructions received by the investigator;
- available to return to the study centre at the protocol visits;
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- accepting to not change the normal life habits regarding: food, physical activity, face cleansing;
- accepting not to receive any other drug/cosmetic treatment able to interfere with the study results;
- accepting to sign the informed consent form (under 18 years the signature of both parents is required).
Who cannot join
- Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
- lactation (only for female subjects);
- subjects whose insufficient adhesion to the study protocol is expected;
- subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
- concomitant participation in other studies or in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.
Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.
Read the detailed description
This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).
The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.
Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.
A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.
- Conditions
- Acne
- Keywords
- acne,comedones, oily skin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| not in therapy (GROUP 1) | A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). | |
| in therapy (GROUP 2) | A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne
Visual evaluations (comedones, dryness, desquamation, papules, pustoles, microcystis) Tissue dielectric constant (superficial and deep hydration), sebumetry and optical colorimetry (skin colour), follicular biopsy, sebutape image analysis
Measured: 1 month
Secondary outcomes (1)
subjects' self assessment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
- Investigators
- Adele Sparavigna, Physician, Principal investigator, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948570
- Sponsor's protocol ID
- E0113
- Acronym
- ANTI-ACNE
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adityan B, Kumari R, Thappa DM. Scoring systems in acne vulgaris. Indian J Dermatol Venereol Leprol. 2009 May-Jun;75(3):323-6. doi: 10.4103/0378-6323.51258. No abstract available.
PubMed 19439902Alanen E, Lahtinen T, Nuutinen J. Penetration of electromagnetic fields of an open-ended coaxial probe between 1 MHz and 1 GHz in dielectric skin measurements. Phys Med Biol. 1999 Jul;44(7):N169-76. doi: 10.1088/0031-9155/44/7/404.
PubMed 10442720Becker W.D., Bajor J.S., Hoyberg K., Hillmer S., Thibouto D., Knaggs H. Measurement Of Human Surface Sebum Levels The Journal of Investigative Dermatology, Vol. 110, No. 4, April 1998
Clarys P.M., Barel A.O. Sebumetry: A comparison between Lipid Collection Techniques. Skin Research and Technology, Vol.2, No.4, Nov.1996
Cunliffe WJ, Shuster S. The rate of sebum excretion in man. Br J Dermatol. 1969 Sep;81(9):697-704. doi: 10.1111/j.1365-2133.1969.tb16211.x. No abstract available.
PubMed 4243403Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, (1991)
Elsner P. Sebum Bioengineering of the Skin: Methods and Instrumentation, CRC Press 1995
Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong
ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996
Kiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D) Skin Res Technol, Vol 11: 292, 2005
Klingman A.M., Miller D.L., McGinley K.J. Sebutape: A device for visualizing and measuring human sebaceous secretion. J. Soc. Cosmet. Chem. 37:369-374, 1896
Lahtinen, T., Nuutinen, J., Alanen, E. Dielectric properties of the skin In: Radio Frequency Radiation Dosimetry. Editors: B. J. Klauenberg and D. Miklavcic. Kluwer Academic Publishers, the Netherlands, 2000
Lahtinen T, Nuutinen J, Alanen E. Dielectric properties of the skin. Phys Med Biol. 1997 Jul;42(7):1471-2. doi: 10.1088/0031-9155/42/7/020. No abstract available.
PubMed 9253055Mayrovitz HN, Luis M. Spatial variations in forearm skin tissue dielectric constant. Skin Res Technol. 2010 Nov;16(4):438-43. doi: 10.1111/j.1600-0846.2010.00456.x.
PubMed 20923455Pierard GE, Pierard-Franchimont C, Le T, Lapiere C. Patterns of follicular sebum excretion rate during lifetime. Arch Dermatol Res. 1987;279 Suppl:S104-7. doi: 10.1007/BF00585931.
PubMed 2959210
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
- ClinicalTrials.gov ID
- NCT01948570
- Acronym / sponsor ID
- ANTI-ACNE / E0113
- Conditions
- Acne
- Keywords
- acne,comedones, oily skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Sep 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.
Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.
Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects.
Detailed description
This is an open controlled clinical trial. The product will be applied for a period of 4 weeks and 3 visits will be performed: a baseline visit (T0), an intermediate visit after 2 weeks (T2) and a final visit after 4 week-treatment (T4).
The subjects will be enrolled and divided in 2 groups according to their acne grade (20 subjects with mild/moderate grade and 20 subjects with moderately severe/severe), a concomitant therapy is allowed only for volunteers with acne moderately severe/severe.
Each volunteer, fulfilling the inclusion criteria, will perform a cosmetic treatment with the study product on all the face, for 4 weeks.
A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| not in therapy (GROUP 1) | – | –A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). |
| in therapy (GROUP 2) | – | –A fixed quantity of the medical device will be applied on the face twice a day, in the morning and in the evening (always at the same hour), with a mild massage according to the instructions received by the investigator during the baseline visit (T0). Group 2 will continue also the standardised treatment with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA until the end of the study |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted on volunteers of both genders, aged > 16 years old: 20 subjects presenting acne of mild/moderate grade not in therapy (GROUP 1) and 20 subjects presenting acne of moderately severe/severe grade in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2).
Key inclusion criteria (9 listed)
- both genders;
- age > 16 years old;
- acne of mild/moderate grade, not in therapy (GROUP 1);
- acne of moderately severe/severe grade, in therapy with topical or systemic retinoids, benzoyl peroxide, clindamycin or AHA (GROUP 2);
- accepting to follow the instructions received by the investigator;
Key exclusion criteria (5 listed)
- Pregnancy (only for female subjects) - for subjects belonging to Group 2, a control pregnancy test could be required at T2 and T4 in case of assumption of an anti-acne drug with potential teratogenic effects; these subjects must confirm to use adequate contraceptive precautions in order to avoid pregnancies;
- lactation (only for female subjects);
- subjects whose insufficient adhesion to the study protocol is expected;
- subjects who changed the anti-acne therapy during the 2 months prior to the study inclusion;
- concomitant participation in other studies or in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne
Time frame: 1 month
Visual evaluations (comedones, dryness, desquamation, papules, pustoles, microcystis) Tissue dielectric constant (superficial and deep hydration), sebumetry and optical colorimetry (skin colour), follicular biopsy, sebutape image analysis
1 secondary outcome
subjects' self assessment
Time frame: 1 month
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 1 Sep 2017.
- Background: PubMed 19439902Adityan B, Kumari R, Thappa DM. Scoring systems in acne vulgaris. Indian J Dermatol Venereol Leprol. 2009 May-Jun;75(3):323-6. doi: 10.4103/0378-6323.51258. No abstract available.
- Background: PubMed 10442720Alanen E, Lahtinen T, Nuutinen J. Penetration of electromagnetic fields of an open-ended coaxial probe between 1 MHz and 1 GHz in dielectric skin measurements. Phys Med Biol. 1999 Jul;44(7):N169-76. doi: 10.1088/0031-9155/44/7/404.
- BackgroundBecker W.D., Bajor J.S., Hoyberg K., Hillmer S., Thibouto D., Knaggs H. Measurement Of Human Surface Sebum Levels The Journal of Investigative Dermatology, Vol. 110, No. 4, April 1998
- BackgroundClarys P.M., Barel A.O. Sebumetry: A comparison between Lipid Collection Techniques. Skin Research and Technology, Vol.2, No.4, Nov.1996
- Background: PubMed 4243403Cunliffe WJ, Shuster S. The rate of sebum excretion in man. Br J Dermatol. 1969 Sep;81(9):697-704. doi: 10.1111/j.1365-2133.1969.tb16211.x. No abstract available.
- BackgroundCurry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, (1991)
- BackgroundElsner P. Sebum Bioengineering of the Skin: Methods and Instrumentation, CRC Press 1995
- BackgroundFernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong
- BackgroundICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996
- BackgroundKiiskinen M., Nuutinen J. and Alanen E. Measurement depths of a skin-water analyzer (MoistureMeter D) Skin Res Technol, Vol 11: 292, 2005
- BackgroundKlingman A.M., Miller D.L., McGinley K.J. Sebutape: A device for visualizing and measuring human sebaceous secretion. J. Soc. Cosmet. Chem. 37:369-374, 1896
- BackgroundLahtinen, T., Nuutinen, J., Alanen, E. Dielectric properties of the skin In: Radio Frequency Radiation Dosimetry. Editors: B. J. Klauenberg and D. Miklavcic. Kluwer Academic Publishers, the Netherlands, 2000
- Investigation centerLink provided by the sponsor.
- Text sponsorLink 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.
Adele Sparavigna, Physician principal investigator
Derming SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Derming SRL at 1 site in Italy.
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 9 inclusion and 5 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 1 Sep 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 Italy. 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.
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?
clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne (time frame: 1 month). 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 NCT01948570, which also lists 22 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 1 Sep 2017.