Cleft LipPhase 3NCT03314090
Silicone Gel in the Treatment of Cleft Lip Scars
A Phase 3 study testing Silicone Gels in people with Cleft Lip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Cleft lip / palate is the most common craniofacial anomaly in humans. Lip repair is one of the most important reconstructions for these patients, and is performed at around 3 months of age. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cleft Lip
- What is being tested?
- Silicone Gels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jan 2014to 12 Oct 2017
- Phase
- Phase 3
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Baby born with cleft lip planned for primary lip repair around 3 months of age,
- Written informed consent for the study provided by the parent/guardian
Who cannot join
- presence of other craniofacial anomalies;
- lack of signed informed consent from the parent/guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Silicone Gel in the Treatment of Cleft Lip Scars
Cleft lip / palate is the most common craniofacial anomaly in humans. Lip repair is one of the most important reconstructions for these patients, and is performed at around 3 months of age. Although the cheiloplasty scar is unavoidable and permanent, every possible measure should be considered to optimize its functional and aesthetic outcome, since the scar can be a lifelong social stigma of a cleft lip operation. Hypertrophic scarring can highlight the scar even further, and is a recognized negative outcome for cheiloplasty. Moreover, with an incidence as high as 36.3% , hypertrophic scars are more common in Asian-Orientals compared to Caucasians.
The population treated at investigator's institution is almost entirely Oriental (Taiwanese). Patients' intrinsic higher risk of hypertrophic scarring has led investigators continuously to try to improve scar quality for them. In 2011, investigator started a double-blinded, randomized, vehicle-controlled, prospective clinical trial to evaluate whether the injection of botulinum toxin A into the orbicularis oris muscle could improve the quality of the cleft lip scar . The results revealed that botulinum toxin injections into the subjacent orbicularis oris muscle produced narrower cheiloplasty scars, but provided no additional benefits in terms of scar pigmentation, vascularity, pliability or height. During that study, the parents of 14% (4/29) of the babies within the control group reported that participant baby had tried, albeit unsuccessfully, to ingest the silicone sheet at night. This caused investigator to question the safety of silicone sheeting on the upper lip in babies.
Silicone is known to be effective for treating and/or preventing hypertrophic scarring . Silicone gel has been shown to prevent hypertrophic scars in median sternotomy wounds 8. Investigators therefore conducted this clinical trial to evaluate whether post-operative use of silicone gel was non-inferior to silicone sheet for preventing hypertrophy of unilateral cleft lip repair scars.
Read the detailed description
The control group consisted of 29 patients who were recruited and became controls for a previous study (Botulinum Toxin to Improve Results in Cleft Lip Repair; IRB No 101-3009C) who were treated using the current established protocol for scar care following cheiloplasty 2. This involved microporous tape placed across both cheeks and spanning the upper lip during daytime, and silicone sheets fixed with a shorter length of microporous tape (that did not span the cheeks) at night. This continued strictly for 6 months.
The Study group consisted of another 33 consecutive age-matched patients with unilateral cleft lip, whose postoperative scar care was exactly the same except the silicone sheet was replaced with silicone gel (Dermatix Ultra, Menarini, Singapore), which was applied twice per day. The parents (or caregivers) were instructed to apply silicone gel (the amount being similar in size to a grain of rice) along the upper lip scar from the nostril base to the vermillion, avoiding the wet mucosa.
Inclusion criteria were: 1. Baby born with cleft lip planned for primary lip repair around 3 months of age, . Written informed consent for the study provided by the parent/guardian. Exclusion criteria were: 1. presence of other craniofacial anomalies; 2. lack of signed informed consent from the parent/guardian.
- Conditions
- Cleft Lip
- Being tested
- Silicone Gels
- Keywords
- Cleft lip, Scar, Silicone sheet, Silicone gel
- Medical subject headings
- Cleft Lip, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone GelsDrug
Also called Dermatix Ultra
silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day. The amount used being similar in size to a grain of rice.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Gel Group | Experimental | Intervention: Silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day (BID). The amount being similar in size to a grain of rice. Receives: Drug: Silicone Gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vacouver scar scale
Pigmentation: 0 normal; 1 hypopigmentation; 2 Hyperpigmentation Vascularity: 0 normal; 1. pink; 2. red; 3. purple Pliability: 0 normal; 1. supple, flexible with minimal resistance; 2. Yielding, giving way to pressure; 3. firm, inflexible, not easily moved, resistant to manual pressure; 4. banding, rope-like tissue that blanches with extension of the scar; 5. contracture, permanent shortening of the scar producing deformity or distortion.
Height: 0. normal; 1. less than 2 mm; 2. less than 5 mm; 3. more than 5 mm The sum of each item give the total scores. The score range from 0-13; with minimum of 0 being the best scar and maximum13 the worst scar
Measured: Six months after surgery
Visual Analogue Scale
VAS with 10 grades: 0 represented the worst possible scar outcome and 10 the best possible scar outcome.
Measured: Six months after surgery
Scar width
A standard frontally oriented photograph was taken with a surgical ruler placed on the lower lip at the six-month follow up clinic. The scar width measurements were obtained from the photographs (using the surgical ruler as the reference) by two independent raters and means calculated. A commercial photograph program for scar width measurement was utilized (Photoshop CS5 extended version 12.0; Adobe Systems Inc, San Jose, California). Scars were measured at two points: the First Point was 1 mm above the white roll; the Second Point was 1 mm below the C-flap suture line.
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start28 Jan 2014
- Primary completion29 Nov 2016
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Testing silicone gel in the treatment of upper lip scar
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314090
- Sponsor's protocol ID
- 102-4719b
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lin TM, Lin TY, Chou CK, Lai CS, Lin SD. Application of microautologous fat transplantation in the correction of sunken upper eyelid. Plast Reconstr Surg Glob Open. 2014 Dec 5;2(11):e259. doi: 10.1097/GOX.0000000000000141. eCollection 2014 Nov.
PubMed 25506542Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.
PubMed 25541942Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.
PubMed 25158709Chernoff WG, Cramer H, Su-Huang S. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation erythema. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):495-500. doi: 10.1007/s00266-006-0218-1.
PubMed 17700980Signorini M, Clementoni MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):183-7. doi: 10.1007/s00266-005-0122-0.
PubMed 17171514Kim S, Choi TH, Liu W, Ogawa R, Suh JS, Mustoe TA. Update on scar management: guidelines for treating Asian patients. Plast Reconstr Surg. 2013 Dec;132(6):1580-1589. doi: 10.1097/PRS.0b013e3182a8070c.
PubMed 24281584Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.
PubMed 12028528
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Silicone Gel in the Treatment of Cleft Lip Scars
- ClinicalTrials.gov ID
- NCT03314090
- Acronym / sponsor ID
- 102-4719b
- Conditions
- Cleft Lip
- Keywords
- Cleft lip, Scar, Silicone sheet, Silicone gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 29 Nov 2016 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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.
Cleft lip / palate is the most common craniofacial anomaly in humans. Lip repair is one of the most important reconstructions for these patients, and is performed at around 3 months of age. Although the cheiloplasty scar is unavoidable and permanent, every possible measure should be considered to optimize its functional and aesthetic outcome, since the scar can be a lifelong social stigma of a cleft lip operation. Hypertrophic scarring can highlight the scar even further, and is a recognized negative outcome for cheiloplasty. Moreover, with an incidence as high as 36.3% , hypertrophic scars are more common in Asian-Orientals compared to Caucasians.
The population treated at investigator's institution is almost entirely Oriental (Taiwanese). Patients' intrinsic higher risk of hypertrophic scarring has led investigators continuously to try to improve scar quality for them. In 2011, investigator started a double-blinded, randomized, vehicle-controlled, prospective clinical trial to evaluate whether the injection of botulinum toxin A into the orbicularis oris muscle could improve the quality of the cleft lip scar . The results revealed that botulinum toxin injections into the subjacent orbicularis oris muscle produced narrower cheiloplasty scars, but provided no additional benefits in terms of scar pigmentation, vascularity, pliability or height. During that study, the parents of 14% (4/29) of the babies within the control group reported that participant baby had tried, albeit unsuccessfully, to ingest the silicone sheet at night. This caused investigator to question the safety of silicone sheeting on the upper lip in babies.
Silicone is known to be effective for treating and/or preventing hypertrophic scarring . Silicone gel has been shown to prevent hypertrophic scars in median sternotomy wounds 8. Investigators therefore conducted this clinical trial to evaluate whether post-operative use of silicone gel was non-inferior to silicone sheet for preventing hypertrophy of unilateral cleft lip repair scars.
Detailed description
The control group consisted of 29 patients who were recruited and became controls for a previous study (Botulinum Toxin to Improve Results in Cleft Lip Repair; IRB No 101-3009C) who were treated using the current established protocol for scar care following cheiloplasty 2. This involved microporous tape placed across both cheeks and spanning the upper lip during daytime, and silicone sheets fixed with a shorter length of microporous tape (that did not span the cheeks) at night. This continued strictly for 6 months.
The Study group consisted of another 33 consecutive age-matched patients with unilateral cleft lip, whose postoperative scar care was exactly the same except the silicone sheet was replaced with silicone gel (Dermatix Ultra, Menarini, Singapore), which was applied twice per day. The parents (or caregivers) were instructed to apply silicone gel (the amount being similar in size to a grain of rice) along the upper lip scar from the nostril base to the vermillion, avoiding the wet mucosa.
Inclusion criteria were: 1. Baby born with cleft lip planned for primary lip repair around 3 months of age, . Written informed consent for the study provided by the parent/guardian. Exclusion criteria were: 1. presence of other craniofacial anomalies; 2. lack of signed informed consent from the parent/guardian.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Testing silicone gel in the treatment of upper lip scar
| Arm | Type | Receives |
|---|---|---|
| Silicone Gel Group | Experimental | Drug: Silicone GelsIntervention: Silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day (BID). The amount being similar in size to a grain of rice. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Baby born with cleft lip planned for primary lip repair around 3 months of age,
- Written informed consent for the study provided by the parent/guardian
Key exclusion criteria (2 listed)
- presence of other craniofacial anomalies;
- lack of signed informed consent from the parent/guardian.
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 |
|---|---|---|
| Silicone GelsAlso: Dermatix Ultrasilicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day. The amount used being similar in size to a grain of rice. | Drug | Silicone Gel Group |
Primary outcome
Vacouver scar scale
Time frame: Six months after surgery
Pigmentation: 0 normal; 1 hypopigmentation; 2 Hyperpigmentation Vascularity: 0 normal; 1. pink; 2. red; 3. purple Pliability: 0 normal; 1. supple, flexible with minimal resistance; 2. Yielding, giving way to pressure; 3. firm, inflexible, not easily moved, resistant to manual pressure; 4. banding, rope-like tissue that blanches with extension of the scar; 5. contracture, permanent shortening of the scar producing deformity or distortion. Height: 0. normal; 1. less than 2 mm; 2. less than 5 mm; 3. more than 5 mm The sum of each item give the total scores. The score range from 0-13; with minimum of 0 being the best scar and maximum13 the worst scar
Visual Analogue Scale
Time frame: Six months after surgery
VAS with 10 grades: 0 represented the worst possible scar outcome and 10 the best possible scar outcome.
Scar width
Time frame: Six months after surgery
A standard frontally oriented photograph was taken with a surgical ruler placed on the lower lip at the six-month follow up clinic. The scar width measurements were obtained from the photographs (using the surgical ruler as the reference) by two independent raters and means calculated. A commercial photograph program for scar width measurement was utilized (Photoshop CS5 extended version 12.0; Adobe Systems Inc, San Jose, California). Scars were measured at two points: the First Point was 1 mm above the white roll; the Second Point was 1 mm below the C-flap suture line.
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 24 Oct 2017.
- Background: PubMed 25506542Lin TM, Lin TY, Chou CK, Lai CS, Lin SD. Application of microautologous fat transplantation in the correction of sunken upper eyelid. Plast Reconstr Surg Glob Open. 2014 Dec 5;2(11):e259. doi: 10.1097/GOX.0000000000000141. eCollection 2014 Nov.
- Background: PubMed 25541942Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.
- Background: PubMed 25158709Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.
- Background: PubMed 17700980Chernoff WG, Cramer H, Su-Huang S. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation erythema. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):495-500. doi: 10.1007/s00266-006-0218-1.
- Background: PubMed 17171514Signorini M, Clementoni MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):183-7. doi: 10.1007/s00266-005-0122-0.
- Background: PubMed 24281584Kim S, Choi TH, Liu W, Ogawa R, Suh JS, Mustoe TA. Update on scar management: guidelines for treating Asian patients. Plast Reconstr Surg. 2013 Dec;132(6):1580-1589. doi: 10.1097/PRS.0b013e3182a8070c.
- Background: PubMed 12028528Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Silicone Gels in people with Cleft Lip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 24 Oct 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 Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
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?
Vacouver scar scale (time frame: Six months after surgery). 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 NCT03314090, which also lists 7 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 24 Oct 2017.