PhotoagingNCT01935310
Photoaging Treatment With Imiquimod
A study testing Imiquimod in people with Photoaging, run by CES University at 1 site in Colombia.
Trial summary
Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin. This is an experimental exploratory study. It included 17 patients. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Imiquimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2010to Aug 2013
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with Fitzpatrick's skin types I to IV, with a photoaging equal to or greater than 3 on the Glogau measuring scale, who had not used systemic retinoids for over four weeks during six months prior to baseline,
- Patients nor had they undergone chemical peels or used exfoliants or applied botulinum toxin or any other abrasive substance on the face six months prior baseline
- patients that had not used topical retinoids or steroids two months prior to baseline
- patients that had not undergone facial rejuvenation surgery 12 months prior to treatment.
Who cannot join
- pregnant or nursing women
- patients currently being treated with phototherapy
- patients currently being treated with photochemotherapy or whom were scheduled to start
- patients with suspected skin cancer assessed by clinical examination
- patients with dermatological conditions with changes in the texture or color of the skin
- Patients with inflammatory dermatoses, immunological, infectious, or neoplastic skin diseases located in the periocular area since it could interfere with the clinical assessment of photoaging.
- Patients that at the time of inclusion expressed treatment refusal, disinterest or inability to comply with the protocol as well as those with skin types V and VI were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Histological Analysis of Photoaging Treatment With Imiquimod Cream 5%
Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin.
This is an experimental exploratory study. It included 17 patients. The patients were diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to participate in the study. Patients were treated with imiquimod 5% topically, for a time period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4 weeks after completing the treatment. Adverse effects, adherence to therapy and patients' satisfaction were measured.
Clinical and histological parameters of photoaging were studied at baseline and after treatment. After completion of treatment with imiquimod, the final clinical evaluation was compared to the initial one.
Read the detailed description
An experimental study was conducted between July and November 2010 in order to evaluate the efficacy and safety of imiquimod as a treatment option for photoaging.
The sample population was made up of individuals from both genders, older than 40 years, who worked at a flower growing farm located in a rural area of Rionegro (Antioquia) with an altitude of 2,125 meters above sea level; approximately composed of 80 people.
The sample size was calculated considering improvements in 50% or more of patients had to be detected, with a confidence interval of 95%, a power of 80%, a sampling error of 5%.
There were five visits: one at baseline and at months 1, 2, 3 and 4. In each visit patients were assesed clinically, a photograph was taken and adherence and side effects were investigated. Treatment was given during the first 3 months. A biopsy was taken at baseline and during the 4th month assessment. The last visit for clinical monitoring, photographic follow up and skin biopsy was at 16 weeks (4 weeks after discontinuation of the medication). In this last visit patient's satisfaction was evaluated through a survey.
The clinical assessment of photodamage performed by two dermatologists independently included: Changes in texture: dryness/roughness; changes in color: mottled hyperpigmentation, lentigines, yellowing; wrinkles: fine, deep wrinkles and laxity; telangiectasias.
Clinical signs like dryness, burning, erythema, itching, fissures and scabs were used to measure skin irritation.
Severity for the parameters measured in the clinical assessment of photoaging and the assessment of skin irritation was graded on a point scale of 0-3 where 0 was absence, one was mild, 2 moderate and 3 severe.
Biopsies were taken from sites adjacent to the temporal facial area. Aseptic iodine solution was used on the selected area, then the biopsy site was infiltrated with lidocaine 2% (about 0.5 cc) with a short 30-gauge needle and once analgesia was obtained a punch biopsy number 4 mm was taken. The skin biopsy was kept in a jar with formalin properly labeled and sent for histopathology. Then the biopsy site was sutured with 5-0 prolene. The biopsies were sent to the pathology department of the CES University for hematoxylin-eosin staining and they were blind - read by two dermatopathologists who evaluated the following parameters: epidermal changes: epidermal thickness, thickness of the granular layer, melanin content, atypia of melanocytes and keratinocytes, dermal-epidermal junction: pigment incontinence; dermis: inflammation, solar elastosis, fibrosis in the papillary dermis and telangiectasia.
Adherence was measured by asking patients in each one of the visits and it was considered excellent when the drug was applied 3 times per week, regular if the patient missed 2-3 applications between visits and poor if he/she missed more than 5 applications.
- Conditions
- Photoaging
- Being tested
- Imiquimod
- Keywords
- Photoaging, imiquimod, wrinkles, elastosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Virosupril®
From the group of subjects who met the inclusion criteria, 22 people were selected randomly (using a random number table) since a 20-25% loss to follow up was calculated and the least amount of patients needed were 17.
During the study participants applied imiquimod cream 5% (Virosupril ® laboratories Roemmers) in the periocular area during the night, three times a week, on nonconsecutive days, for 12 weeks (3 months). If patients presented irritative dermatitis a topical 0.05% desonide cream was administered and applied for less of 5 days until symptoms improved.
| Study group | Role | What they receive |
|---|---|---|
| imiquimod use in photoaging | Experimental | Evaluate the efficacy and safety of imiquimod as a treatment option for photoaging photoaging equal to or greater than 3. Receives: Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical response by percentage of improvement
To determine the degree of patient improvement percentages were set according to the values obtained in the first and last measurement as follows:
For ordinal clinical variables that had 4 categories the following percentages were established: Slight 1-point improvement (1-32%), moderate 2-point improvement (33-66%), good 3-point improvement (> 66%), same or worse, one or more points of deterioration (<= 0%).
For ordinal histological variables that were 4 categories the calculated improvement percentages were equal to the ones just described and for those with 5 variables, the established percentages were as follows: Slight 1-point improvement (1-25%), moderate 2-point improvement (26-50%), good 3-point improvement (51-75%), excellent 4-point improvement (> 75%), one or more points of deterioration (<= 0%).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sol Beatriz Jiménez, CES University
- Investigators
- Sol Beatriz Jiménez, MD, Study director, CES UniversityLucía Salinas, MD, Principal investigator, CES UniversityAna Cristina Ruíz, MD, Principal investigator, CES UniversityNatalia De la Calle, MD, Principal investigator, CES UniversityMaría Alejandra Zuluaga, MD, Principal investigator, CES UniversityRubén Darío Manrique, PhC, Principal investigator, CES UniversityBibiana Castro, MSc, Principal investigator, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935310
- Sponsor's protocol ID
- IMQ003
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giacomoni PU, Declercq L, Hellemans L, Maes D. Aging of human skin: review of a mechanistic model and first experimental data. IUBMB Life. 2000 Apr;49(4):259-63. doi: 10.1080/15216540050033104.
PubMed 10995026Glogau RG. Physiologic and structural changes associated with aging skin. Dermatol Clin. 1997 Oct;15(4):555-9. doi: 10.1016/s0733-8635(05)70465-4.
PubMed 9348456Fisher GJ, Wang ZQ, Datta SC, Varani J, Kang S, Voorhees JJ. Pathophysiology of premature skin aging induced by ultraviolet light. N Engl J Med. 1997 Nov 13;337(20):1419-28. doi: 10.1056/NEJM199711133372003.
PubMed 9358139Quan T, He T, Kang S, Voorhees JJ, Fisher GJ. Solar ultraviolet irradiation reduces collagen in photoaged human skin by blocking transforming growth factor-beta type II receptor/Smad signaling. Am J Pathol. 2004 Sep;165(3):741-51. doi: 10.1016/s0002-9440(10)63337-8.
PubMed 15331399Fisher GJ, Talwar HS, Lin J, Voorhees JJ. Molecular mechanisms of photoaging in human skin in vivo and their prevention by all-trans retinoic acid. Photochem Photobiol. 1999 Feb;69(2):154-7. doi: 10.1562/0031-8655(1999)0692.3.co;2.
PubMed 10048311Rabe JH, Mamelak AJ, McElgunn PJ, Morison WL, Sauder DN. Photoaging: mechanisms and repair. J Am Acad Dermatol. 2006 Jul;55(1):1-19. doi: 10.1016/j.jaad.2005.05.010.
PubMed 16781287Metcalf S, Crowson AN, Naylor M, Haque R, Cornelison R. Imiquimod as an antiaging agent. J Am Acad Dermatol. 2007 Mar;56(3):422-5. doi: 10.1016/j.jaad.2006.10.034. Epub 2006 Dec 20.
PubMed 17184874Ohnishi Y, Tajima S, Akiyama M, Ishibashi A, Kobayashi R, Horii I. Expression of elastin-related proteins and matrix metalloproteinases in actinic elastosis of sun-damaged skin. Arch Dermatol Res. 2000 Jan;292(1):27-31. doi: 10.1007/pl00007457.
PubMed 10664012Weinstein GD, Nigra TP, Pochi PE, Savin RC, Allan A, Benik K, Jeffes E, Lufrano L, Thorne EG. Topical tretinoin for treatment of photodamaged skin. A multicenter study. Arch Dermatol. 1991 May;127(5):659-65.
PubMed 2024983Kang SS, Kauls LS, Gaspari AA. Toll-like receptors: applications to dermatologic disease. J Am Acad Dermatol. 2006 Jun;54(6):951-83; quiz 983-6. doi: 10.1016/j.jaad.2005.05.004.
PubMed 16713451Dockrell DH, Kinghorn GR. Imiquimod and resiquimod as novel immunomodulators. J Antimicrob Chemother. 2001 Dec;48(6):751-5. doi: 10.1093/jac/48.6.751.
PubMed 11733457Sauder DN, Mofid MZ. Topical immunotherapy: what's new. Dermatol Clin. 2005 Apr;23(2):245-58. doi: 10.1016/j.det.2004.08.002.
PubMed 15837154Schon M, Schon MP. The antitumoral mode of action of imiquimod and other imidazoquinolines. Curr Med Chem. 2007;14(6):681-7. doi: 10.2174/092986707780059625.
PubMed 17346155Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.
PubMed 17257431McInturff JE, Modlin RL, Kim J. The role of toll-like receptors in the pathogenesis and treatment of dermatological disease. J Invest Dermatol. 2005 Jul;125(1):1-8. doi: 10.1111/j.0022-202X.2004.23459.x.
PubMed 15982296
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Analysis of Photoaging Treatment With Imiquimod Cream 5%
- ClinicalTrials.gov ID
- NCT01935310
- Acronym / sponsor ID
- IMQ003
- Conditions
- Photoaging
- Keywords
- Photoaging, imiquimod, wrinkles, elastosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 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.
Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre malignant and malignant lesions caused by UV radiation it reverses histopathological changes associated with the photoaging skin.
This is an experimental exploratory study. It included 17 patients. The patients were diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to participate in the study. Patients were treated with imiquimod 5% topically, for a time period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4 weeks after completing the treatment. Adverse effects, adherence to therapy and patients' satisfaction were measured.
Clinical and histological parameters of photoaging were studied at baseline and after treatment. After completion of treatment with imiquimod, the final clinical evaluation was compared to the initial one.
Detailed description
An experimental study was conducted between July and November 2010 in order to evaluate the efficacy and safety of imiquimod as a treatment option for photoaging.
The sample population was made up of individuals from both genders, older than 40 years, who worked at a flower growing farm located in a rural area of Rionegro (Antioquia) with an altitude of 2,125 meters above sea level; approximately composed of 80 people.
The sample size was calculated considering improvements in 50% or more of patients had to be detected, with a confidence interval of 95%, a power of 80%, a sampling error of 5%.
There were five visits: one at baseline and at months 1, 2, 3 and 4. In each visit patients were assesed clinically, a photograph was taken and adherence and side effects were investigated. Treatment was given during the first 3 months. A biopsy was taken at baseline and during the 4th month assessment. The last visit for clinical monitoring, photographic follow up and skin biopsy was at 16 weeks (4 weeks after discontinuation of the medication). In this last visit patient's satisfaction was evaluated through a survey.
The clinical assessment of photodamage performed by two dermatologists independently included: Changes in texture: dryness/roughness; changes in color: mottled hyperpigmentation, lentigines, yellowing; wrinkles: fine, deep wrinkles and laxity; telangiectasias.
Clinical signs like dryness, burning, erythema, itching, fissures and scabs were used to measure skin irritation.
Severity for the parameters measured in the clinical assessment of photoaging and the assessment of skin irritation was graded on a point scale of 0-3 where 0 was absence, one was mild, 2 moderate and 3 severe.
Biopsies were taken from sites adjacent to the temporal facial area. Aseptic iodine solution was used on the selected area, then the biopsy site was infiltrated with lidocaine 2% (about 0.5 cc) with a short 30-gauge needle and once analgesia was obtained a punch biopsy number 4 mm was taken. The skin biopsy was kept in a jar with formalin properly labeled and sent for histopathology. Then the biopsy site was sutured with 5-0 prolene. The biopsies were sent to the pathology department of the CES University for hematoxylin-eosin staining and they were blind - read by two dermatopathologists who evaluated the following parameters: epidermal changes: epidermal thickness, thickness of the granular layer, melanin content, atypia of melanocytes and keratinocytes, dermal-epidermal junction: pigment incontinence; dermis: inflammation, solar elastosis, fibrosis in the papillary dermis and telangiectasia.
Adherence was measured by asking patients in each one of the visits and it was considered excellent when the drug was applied 3 times per week, regular if the patient missed 2-3 applications between visits and poor if he/she missed more than 5 applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imiquimod use in photoaging | Experimental | Drug: ImiquimodEvaluate the efficacy and safety of imiquimod as a treatment option for photoaging photoaging equal to or greater than 3. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with Fitzpatrick's skin types I to IV, with a photoaging equal to or greater than 3 on the Glogau measuring scale, who had not used systemic retinoids for over four weeks during six months prior to baseline,
- Patients nor had they undergone chemical peels or used exfoliants or applied botulinum toxin or any other abrasive substance on the face six months prior baseline
- patients that had not used topical retinoids or steroids two months prior to baseline
- patients that had not undergone facial rejuvenation surgery 12 months prior to treatment.
Key exclusion criteria (7 listed)
- pregnant or nursing women
- patients currently being treated with phototherapy
- patients currently being treated with photochemotherapy or whom were scheduled to start
- patients with suspected skin cancer assessed by clinical examination
- patients with dermatological conditions with changes in the texture or color of the skin
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 |
|---|---|---|
| ImiquimodAlso: Virosupril®From the group of subjects who met the inclusion criteria, 22 people were selected randomly (using a random number table) since a 20-25% loss to follow up was calculated and the least amount of patients needed were 17. During the study participants applied imiquimod cream 5% (Virosupril ® laboratories Roemmers) in the periocular area during the night, three times a week, on nonconsecutive days, for 12 weeks (3 months). If patients presented irritative dermatitis a topical 0.05% desonide cream was administered and applied for less of 5 days until symptoms improved. | Drug | imiquimod use in photoaging |
Primary outcome
Evaluation of clinical response by percentage of improvement
Time frame: 8 weeks
To determine the degree of patient improvement percentages were set according to the values obtained in the first and last measurement as follows: For ordinal clinical variables that had 4 categories the following percentages were established: Slight 1-point improvement (1-32%), moderate 2-point improvement (33-66%), good 3-point improvement (> 66%), same or worse, one or more points of deterioration (<= 0%). For ordinal histological variables that were 4 categories the calculated improvement percentages were equal to the ones just described and for those with 5 variables, the established percentages were as follows: Slight 1-point improvement (1-25%), moderate 2-point improvement (26-50%), good 3-point improvement (51-75%), excellent 4-point improvement (> 75%), one or more points of deterioration (<= 0%).
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 5 Sep 2013.
- Background: PubMed 10995026Giacomoni PU, Declercq L, Hellemans L, Maes D. Aging of human skin: review of a mechanistic model and first experimental data. IUBMB Life. 2000 Apr;49(4):259-63. doi: 10.1080/15216540050033104.
- Background: PubMed 9348456Glogau RG. Physiologic and structural changes associated with aging skin. Dermatol Clin. 1997 Oct;15(4):555-9. doi: 10.1016/s0733-8635(05)70465-4.
- Background: PubMed 9358139Fisher GJ, Wang ZQ, Datta SC, Varani J, Kang S, Voorhees JJ. Pathophysiology of premature skin aging induced by ultraviolet light. N Engl J Med. 1997 Nov 13;337(20):1419-28. doi: 10.1056/NEJM199711133372003.
- Background: PubMed 15331399Quan T, He T, Kang S, Voorhees JJ, Fisher GJ. Solar ultraviolet irradiation reduces collagen in photoaged human skin by blocking transforming growth factor-beta type II receptor/Smad signaling. Am J Pathol. 2004 Sep;165(3):741-51. doi: 10.1016/s0002-9440(10)63337-8.
- Background: PubMed 10048311Fisher GJ, Talwar HS, Lin J, Voorhees JJ. Molecular mechanisms of photoaging in human skin in vivo and their prevention by all-trans retinoic acid. Photochem Photobiol. 1999 Feb;69(2):154-7. doi: 10.1562/0031-8655(1999)0692.3.co;2.
- Background: PubMed 16781287Rabe JH, Mamelak AJ, McElgunn PJ, Morison WL, Sauder DN. Photoaging: mechanisms and repair. J Am Acad Dermatol. 2006 Jul;55(1):1-19. doi: 10.1016/j.jaad.2005.05.010.
- Background: PubMed 17184874Metcalf S, Crowson AN, Naylor M, Haque R, Cornelison R. Imiquimod as an antiaging agent. J Am Acad Dermatol. 2007 Mar;56(3):422-5. doi: 10.1016/j.jaad.2006.10.034. Epub 2006 Dec 20.
- Background: PubMed 10664012Ohnishi Y, Tajima S, Akiyama M, Ishibashi A, Kobayashi R, Horii I. Expression of elastin-related proteins and matrix metalloproteinases in actinic elastosis of sun-damaged skin. Arch Dermatol Res. 2000 Jan;292(1):27-31. doi: 10.1007/pl00007457.
- Background: PubMed 2024983Weinstein GD, Nigra TP, Pochi PE, Savin RC, Allan A, Benik K, Jeffes E, Lufrano L, Thorne EG. Topical tretinoin for treatment of photodamaged skin. A multicenter study. Arch Dermatol. 1991 May;127(5):659-65.
- Background: PubMed 16713451Kang SS, Kauls LS, Gaspari AA. Toll-like receptors: applications to dermatologic disease. J Am Acad Dermatol. 2006 Jun;54(6):951-83; quiz 983-6. doi: 10.1016/j.jaad.2005.05.004.
- Background: PubMed 11733457Dockrell DH, Kinghorn GR. Imiquimod and resiquimod as novel immunomodulators. J Antimicrob Chemother. 2001 Dec;48(6):751-5. doi: 10.1093/jac/48.6.751.
- Background: PubMed 15837154Sauder DN, Mofid MZ. Topical immunotherapy: what's new. Dermatol Clin. 2005 Apr;23(2):245-58. doi: 10.1016/j.det.2004.08.002.
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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.
Sol Beatriz Jiménez, MD study director
CES University
Lucía Salinas, MD principal investigator
CES University
Ana Cristina Ruíz, MD principal investigator
CES University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imiquimod in people with Photoaging, run by CES University at 1 site in Colombia.
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 4 inclusion and 7 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 5 Sep 2013. 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 Colombia. 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?
Evaluation of clinical response by percentage of improvement (time frame: 8 weeks). 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 NCT01935310, which also lists 19 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 5 Sep 2013.